risedronic acid

Change in Pain Interference Score

Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00051636)
Timeframe: Baseline and day 182

Change in Pain Severity Score

Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00051636)
Timeframe: Baseline and day 182

Number of Participants With a Disease Relapse During the Extended Observation Period

Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value. (NCT00051636)
Timeframe: 8 years was the maximum

Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period

Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase. (NCT00051636)
Timeframe: 8 years was the maximum

Number of Participants With a Partial Disease Relapse During the Extended Observation Period

Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit. (NCT00051636)
Timeframe: 8 years was the maximum

Number of Patients Who Achieve Therapeutic Response at 6 Months.

Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months. (NCT00051636)
Timeframe: 6 months

Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline

Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. (NCT00051636)
Timeframe: Baseline and day 28

Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28

The percent change in serum alkaline phosphatase from baseline to day 28 was measured. (NCT00051636)
Timeframe: Baseline and day 28

Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

The percent change in serum C-telopeptide from baseline to day 10 was measured. (NCT00051636)
Timeframe: Baseline and day 10

Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10

The percent change in urine alpha C-telopeptide from baseline to day 10 was measured. (NCT00051636)
Timeframe: Baseline and day 10

Time to First Therapeutic Response

A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase. (NCT00051636)
Timeframe: 182 days

Fat Pounds

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition (NCT03411902)
Timeframe: 24 weeks

Lean Pounds

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition (NCT03411902)
Timeframe: 24 weeks

Number of Enrolled Participants That Completed All 24 Week Procedures

(NCT03411902)
Timeframe: 24 weeks

Total Change in Femoral Neck Hip Density

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2 (NCT03411902)
Timeframe: Baseline and 24 weeks

Total Change in Lumbar Spine Density

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2 (NCT03411902)
Timeframe: Baseline and 24 weeks

Trabecular Bone Score (TBS)

TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS >=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS <=1.200 defines degraded microarchitecture (NCT03411902)
Timeframe: 24 weeks

Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density

Total change in ultradistal radius density measure in g/cm^2 (NCT03411902)
Timeframe: 24 weeks

Change in Pain Interference at Day 182

Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00103740)
Timeframe: Baseline and day 182

Change in Pain Severity at Day 182

Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. (NCT00103740)
Timeframe: Baseline and day 182

Number of Participants With a Disease Relapse During the Extended Observation Period

Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value. (NCT00103740)
Timeframe: 8 years was maximum

Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period

Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase. (NCT00103740)
Timeframe: 8 years was the maximum

Number of Participants With a Partial Disease Relapse During the Extended Observation Period

Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit. (NCT00103740)
Timeframe: 8 years was the maximum

Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28

Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years). (NCT00103740)
Timeframe: Day 28

Number of Patients Who Had Therapeutic Response at 6 Months

A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months. (NCT00103740)
Timeframe: Baseline, 6 months

Relative Change in Serum Alkaline Phosphatase in U/L at Day 28

The percent change in serum alkaline phosphatase from baseline to Day 28 was measured. (NCT00103740)
Timeframe: Baseline and 28 days

Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

The percent change in serum C-telopeptide from baseline to Day 10 was measured. (NCT00103740)
Timeframe: Baseline and day 10

Relative Change in Urine α-CTx in ug/mmol at Day 10

The percent change in urine α-CTx from baseline to Day 10 was measured. (NCT00103740)
Timeframe: Baseline and day 10

Time to First Therapeutic Response

Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase. (NCT00103740)
Timeframe: 182 days

Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)

To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used. (NCT01077817)
Timeframe: Up to approximately 7.3 years of follow-up

Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)

To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review. (NCT01077817)
Timeframe: Exposure to study drug at least 720 days before disease onset

Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Change From Baseline in Body Height, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

Change From Baseline in Body Height, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

Cumulative Incidence of Fractures, 12 Months, ITT Population

Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year (NCT00619957)
Timeframe: Baseline to Month 12

Cumulative Incidence of Fractures, 24 Months, ITT Population

Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years (NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 3

Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in BAP, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in BAP, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in BAP, Month 6, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 6

Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 3

Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in CTx, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in CTx, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in CTx, Month 6, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 6

Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008 (NCT00619957)
Timeframe: Baseline to Month 6

Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. (NCT00619957)
Timeframe: Baseline to Month 6

Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to Month 6

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 3

Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.

(NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.

(NCT00619957)
Timeframe: Baseline to Month 6

Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to 24 Months/Endpoint

Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to Month 12

Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to Month 24

Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). (NCT00619957)
Timeframe: Baseline to Month 6

Percent of Responders Lumbar Spine BMD, Month 24, ITT Population

responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24 (NCT00619957)
Timeframe: Baseline to Month 24

Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Number of Patients With at Least One New Fractured Vertebra, Week 52

(NCT00541658)
Timeframe: Week 52

Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint

(NCT00541658)
Timeframe: Week 104 / Endpoint

Number of Patients With No New Fractured Vertebra, Week 104

(NCT00541658)
Timeframe: Week 104

Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint

(NCT00541658)
Timeframe: Week 52 / Endpoint

Number of Patients With No New Fractured Vertebra, Week 52

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population

(NCT00541658)
Timeframe: Week 13

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: 52 weeks / Endpoint

Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population

(NCT00541658)
Timeframe: Week 13

Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 104 / Endpoint

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population

(NCT00541658)
Timeframe: Week 104

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population

(NCT00541658)
Timeframe: Week 26

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population

(NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population

(NCT00541658)
Timeframe: Week 52

Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population

(NCT00541658)
Timeframe: Week 13

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52 / Endpoint

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population

Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. (NCT00541658)
Timeframe: Week 52

Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at 12 Months

bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 12 months (NCT00452439)
Timeframe: 12 months

Bone Loss Reduction: Mean Percent Changes in BMD for Each Treatment Arm at the 6 Months

bone mineral density (BMD) Mean percent Change in Bone Density from Baseline to 6 months. (NCT00452439)
Timeframe: 6 months

Bone Mineral Density of Forearm at 12 Months

Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 12 of the treatment

Bone Mineral Density of Forearm at 6 Months

Bone mineral density (BMD) of the distal third of the nondialysis access forearm were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 6 of the treatment

Bone Mineral Density of Spine at 12 Months

Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using same Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 12 of treatment

Bone Mineral Density of Spine at 6 Months

Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 6 of the treatment

Bone Mineral Density of the Hip at 12 Months

Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 12 of the treatment

Bone Mineral Density of the Hip at 6 Months

Bone mineral density (BMD) of the total hip were measured using the Hologic 4500 QDC scanner. (NCT00266708)
Timeframe: month 6 of the treatment

Bone Histomorphometry - Bone Formation Rate

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone formation rate (BFR) indicates how much of the bone is actively mineralizing; it is determined by the number of active OB and the average work of each OB. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Mineralized Bone Volume (MdV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Bone mineralization is the process of laying down minerals on the matrix of the bone, with calcium and phosphorus as the most abundant minerals. Mineralized Bone Volume (MdV) is the percentage of mineralized bone tissue. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Osteoid Volume (OV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the Osteoid Volume (OV), the volume of bone that consists of unmineralized bone. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Bone Volume (BV/TV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Bone Volume is the percentage of total volume occupied by calcified bone. Percent Bone volume is calculated as Bone Volume (BV) divided by Tissue Volume (TV), where TV is bone plus marrow. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secret digestive enzymes tha break up or dissolve the bone tissue. An eroded surface (ES) is the surface of the lacuna ( a cavity or depression in the bone) generated by an active OC. The reported values indicate the percent of eroded surface relative to bone surface (BS). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Percent Mineralized Bone Volume is the percentage of Bone Volume consisting of mineralized bone. Percent Mineralized Bone Volume is calculated as Mineralized Bone Volume (MdV) divided by Bone Volume (BV). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoblasts (OB) are cells that make bones by producing a matrix that becomes mineralized. Bone mass is a balance between the osteoblasts (OB) that form the bone and cells called osteoclasts (OC) that break down the bone. The reported values indicate the percent of bone surface (BS) that is made up of osteoblasts (OB). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoclasts (OC) are cells responsible for bone resorption, which is the breaking down of bones. Osteoclasts make and secrete digestive enzymes that break up or dissolve the bone tissue. Bone mass is a balance between the osteoblasts (OB) cells that form the bone and the osteoclasts (OC) cells that break down the bone. The reported values indicate the percent of bone surface (BS) that consists of osteoclasts (OC). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of bone surface that consists of unmineralized bone. It is equal to Osteoid Surface (OS) divided by Bone Surface (BS). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of bone that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Bone Volume (BV). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. Osteoid is the unmineralized, organic portion of the bone matrix that forms prior to the maturation of bone tissue. The reported values indicates the percent of a given volume of tissue (bone + marrow) that consists of unmineralized bone. It is equal to Osteoid Volume (OV) divided by Tissue Volume (TV). (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Bone Histomorphometry - Trabecular Thickness (TbTh)

Bone histomorphometry is quantitative information on bone remodeling and structure, obtained through examination of an undecalcified bone biopsy. The ends of certain bones, known as cancellous bones, are actually not solid but are full of holes that are connected to each other by thin rods and plates of bone tissue known as trabeculae. Trabeculae of bone provide structural support to the spongy bone found at the ends of long bones. Trabeculae Trabecular Thickness (TbTh), a structural parameter, is the distance across individual trabecula. (NCT00266708)
Timeframe: Baseline and month 12 of the treatment

Change in Lumbar Spine Areal Bone Mineral Density (BMD)

Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). (NCT00887354)
Timeframe: Baseline, Week 78

"Timed Up and Go Test"

"Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score." (NCT00887354)
Timeframe: 6, 12, 18, and 26 Weeks

Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire

SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No). (NCT00887354)
Timeframe: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26

Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb

"Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .~Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use." (NCT00887354)
Timeframe: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78

Change in Lumbar Spine Areal Bone Mineral Density

Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No). (NCT00887354)
Timeframe: Baseline, Week 26; Baseline, Week 52

Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale

Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous. (NCT00887354)
Timeframe: Baseline

Visual Analog Scale (VAS)

Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction. (NCT00887354)
Timeframe: 6, 12, 18, and 26 Weeks

Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00343252)
Timeframe: Baseline, 12 Months

Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. (NCT00343252)
Timeframe: Baseline, 12 Months

Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. (NCT00343252)
Timeframe: Baseline, 18 Months

Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for. (NCT00343252)
Timeframe: Baseline, 18 Months

Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00343252)
Timeframe: Baseline, 3 Months

Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.

Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). (NCT00343252)
Timeframe: Baseline, 6 Months

Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. (NCT00343252)
Timeframe: Baseline, 6 Months

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. (NCT00343252)
Timeframe: Baseline through 18 Months

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months

Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. (NCT00343252)
Timeframe: Baseline through 18 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 12 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 18 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 6 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 12 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 18 Months

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint

24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint. (NCT00343252)
Timeframe: 6 Months

Number of Participants With Adverse Events (Safety) During 12 Months

Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section. (NCT00343252)
Timeframe: Baseline through 12 Months

Number of Participants With Adverse Events (Safety) During 18 Months

Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section. (NCT00343252)
Timeframe: Baseline through 18 Months

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months

Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months

Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months

Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days. (NCT00343252)
Timeframe: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300

Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.

BMD was measured by Dual X-ray Absorptiometry (DXA). (NCT00365456)
Timeframe: 12 months

Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Femoral Neck BMD, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Greater Trochanter BMD, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Height, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Lumbar Spine BMD, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12

Electrochemiluminescence assay method by central lab (NCT00386360)
Timeframe: Baseline and Month 12

Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12

(NCT00386360)
Timeframe: Baseline and Month 12

Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12

ELISA / enzyme-linked immunosorbent assay method by central lab (NCT00386360)
Timeframe: Baseline and Month 12

Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months

Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months

Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months

Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 18 months

Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months, 18 months

Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months

Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip. (NCT00503399)
Timeframe: Baseline, 18 months

Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength

Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months, 18 months

Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months

Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial. (NCT00503399)
Timeframe: Baseline, 6 months, 18 months

Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months

P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid. (NCT00503399)
Timeframe: Baseline, 3 months, 6 months, 18 months

Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months

β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix. (NCT00503399)
Timeframe: 3, 6, 18 months

Number of Participants With Adverse Events (AEs)

Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]). (NCT00503399)
Timeframe: Baseline up to 18 months

Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate

Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. (NCT00377234)
Timeframe: within 6 months

Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing

Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. (NCT00377234)
Timeframe: at 6 months

Intensity of Upper Gastrointestinal (GI) Symptoms

Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list. (NCT00377234)
Timeframe: within 3 months

Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population

(NCT00577720)
Timeframe: Baseline and Week 13

Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population

(NCT00577720)
Timeframe: Baseline and Week 13

Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population

(NCT00577720)
Timeframe: Baseline and Week 13

Change From Baseline in Height

(NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment. (NCT02089997)
Timeframe: Up to Month 12

Number of Participants Who Had Lumbar Backache at Final Assessment

(NCT02089997)
Timeframe: Final assessment (Month 12)

Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment

Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Percent Change From Baseline in Radius BMD at Final Assessment

BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline. (NCT02089997)
Timeframe: Baseline and final assessment (up to Month 12)

Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population

Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)] (NCT00106028)
Timeframe: Baseline and Month 12

Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population

Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)] (NCT00106028)
Timeframe: Baseline and Month 36

Bone Age (Years), Change From Baseline to Month 12, ITT Population

Bone Age determined by visual assessment of hand / wrist radiographs. (NCT00106028)
Timeframe: Baseline and Month 12

Bone Age (Years), Change From Baseline to Month 24, ITT Population

Bone Age determined by visual assessment of hand / wrist radiographs. (NCT00106028)
Timeframe: Baseline and Month 24

Bone Age (Years), Change From Baseline to Month 36, ITT Population

Bone Age determined by visual assessment of hand / wrist radiographs. (NCT00106028)
Timeframe: Baseline and Month 36

Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population

"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 12

Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population

"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 24

Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population

"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values." (NCT00106028)
Timeframe: Baseline and Month 36

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 12

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 24

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 36

Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population

Measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 12

Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population

Measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 24

Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population

Measured by DXA. (NCT00106028)
Timeframe: Baseline and Month 36

Percent Change From Baseline in Total Body BMC at Month 12, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 12

Percent Change From Baseline in Total Body BMC at Month 24, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 24

Percent Change From Baseline in Total Body BMC at Month 36, ITT Population

(NCT00106028)
Timeframe: Baseline and Month 36

Percent Change From Baseline in Total Body BMD at Month 12, ITT Population