alendronate and Spinal Fractures

alendronate has been researched along with Spinal Fractures in 175 studies

alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.

Spinal Fractures: Broken bones in the vertebral column.

Research

Studies (175)

Authors

Clinical Trials (20)

Trial Overview

Trial Outcomes

Number of Participants With New Vertebral Fractures at 18 Months

(NCT01343004)
Timeframe: 18 months

Number of Participants With Non-vertebral Fractures at 18 Months

(NCT01343004)
Timeframe: 18 months

Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

(NCT01343004)
Timeframe: 18 months

Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

(NCT01343004)
Timeframe: Baseline and 18 months

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

(NCT01343004)
Timeframe: Basline and 18 months

Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

(NCT01343004)
Timeframe: Baseline and 18 months

Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline

Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)

Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41*ULN), Prothrombin Time (≥1.21*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)

Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (>5000 cells/mm^3), Absolute Lymphocytes (≤499 cells/mm^3), Absolute Neutrophils (≤999 cells/mm^3), % Eosinophils (>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm^3), and White Blood Cells (Low: ≤1499 cells/mm^3; High: ≥20001 cells/mm^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)

Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter [mEq/L]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (<2.5 grams [g]/deciliter [dL]), total protein (<5 g/dL), glucose (Low: ≤54; High: >125 mg/dL [fasting] or >200 milligrams [mg]/dL [random]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1*upper limit of normal [ULN]), alanine aminotransferase (ALT) (≥5.1*ULN), alkaline phosphatase (AP) (≥3.1*ULN), total bilirubin (≥1.51*ULN [with any increase in liver function tests] ≥2.0*ULN [with normal liver function tests]), creatine kinase (≥3.1*ULN), total cholesterol (>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)

Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (>50 red blood cells per high-power field [rbc/hpf]). (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)

A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 12

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 12

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 24

Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 12

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 24

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 36

Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 36

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 24

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. (NCT01631214)
Timeframe: Baseline and month 36

Percentage of Participants With a Clinical Fracture at the Primary Analysis

All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Percentage of Participants With a Clinical Fracture Through Month 12

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 12 months

Percentage of Participants With a Clinical Fracture Through Month 24

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 24 months

Percentage of Participants With a Clinical Vertebral Fracture Through Month 12

A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic. (NCT01631214)
Timeframe: 12 months

Percentage of Participants With a Clinical Vertebral Fracture Through Month 24

A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic. (NCT01631214)
Timeframe: 24 months

Percentage of Participants With a Hip Fracture at the Primary Analysis

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Percentage of Participants With a Hip Fracture Through Month 12

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. (NCT01631214)
Timeframe: 12 months

Percentage of Participants With a Hip Fracture Through Month 24

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. (NCT01631214)
Timeframe: 24 months

Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis

Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Percentage of Participants With a Major Osteoporotic Fracture Through Month 12

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 12 months

Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24

"A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method." (NCT01631214)
Timeframe: 24 months

Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis

A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Percentage of Participants With a Nonvertebral Fracture Through Month 12

A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 12 months

Percentage of Participants With a Nonvertebral Fracture Through Month 24

A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. (NCT01631214)
Timeframe: 24 months

Percentage of Participants With Any Fracture at the Primary Analysis

All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. (NCT01631214)
Timeframe: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Percentage of Participants With Any Fracture Through Month 12

All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. (NCT01631214)
Timeframe: 12 months

Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader. (NCT01631214)
Timeframe: 24 months

Percentage of Participants With New Vertebral Fractures Through Month 12

"New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader." (NCT01631214)
Timeframe: 12 months

Percentage of Participants With New Vertebral Fractures Through Month 24

"All fracture assessments were performed by blinded central imaging readers.~New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method." (NCT01631214)
Timeframe: 24 months

Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3

Change in dynamic histomorphometry indices was assessed in the cancellous envelope. BFR/BS was reported as cubic millimeter/square millimeter/year (mm^3/mm^2/year). (NCT03710889)
Timeframe: Baseline (Day 1), Month 3

Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3

Change in dynamic histomorphometry indices was assessed in the cancellous envelope. (NCT03710889)
Timeframe: Baseline (Day 1), Month 3

Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3

Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3

Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3

Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3

Number of Participants in Which CTX Increased Above the Least Significant Change

"Number of participants in which CTX increased above the least significant change.~The Department of Clinical Biochemistry, Rigshospitalet, Glostrup, Denmark provided the the least significant change for p-CTX > 30%." (NCT03051620)
Timeframe: From baseline to month 24

If Baseline Bone Turnover Markers at the Time of Alendronate Discontinuation Predict Changes in BMD After One and Two Years.

We constructed receiver operating characteristic (ROC) curves to evaluate if baseline p-CTX or baseline p-PINP at the time of alendronate discontinuation predicted TH BMD loss above the least significant change at month 12 and/or month 24 at the individual level. (NCT03051620)
Timeframe: Changes in TH BMD after one and two years.

If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level.

We constructed receiver operating characteristic (ROC) curves to evaluate if carboxy-terminal collagen crosslinks (CTX) three and six months after stopping alendronate predicted TH BMD loss above the least significant change (LSC) at month 12 at the individual level. (NCT03051620)
Timeframe: Baseline and one year after baseline

Percent Change in Bone Turnover Markers Measured Three and Six Months After Stopping Alendronate Treatment and BMD After One and Two Years

We constructed receiver operating characteristic (ROC) curves to evaluate if changes in p-CTX or p-PINP measured three and six months after stopping alendronate predicted TH BMD loss above the least significant change at month 12 and/or month 24 at the individual level. (NCT03051620)
Timeframe: one and two years after baseline

The Number of Participants Who Lost BMD Beyond the Least Significant Change (LSC) at the Lumbar Spine and Total Hip.

the number of patients who lost BMD beyond the LSC at the lumbar spine (>3%) and total hip (>5%) (NCT03051620)
Timeframe: from baseline to month 24

Changes in Bone Mineral Density of the Distal 1/3 Radius.

(NCT00853723)
Timeframe: 90 days

Changes in Bone Mineral Density of the Femoral Neck.

(NCT00853723)
Timeframe: 90 days

Changes in Bone Mineral Density of the Forearm.

(NCT00853723)
Timeframe: 90 days

Changes in Bone Mineral Density of the Lumbar Spine.

(NCT00853723)
Timeframe: 90 days

Changes in Bone Mineral Density of the Total Hip.

(NCT00853723)
Timeframe: 90 days

1,25 Vitamin D

(NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

24 Hour Urine Calcium

(NCT00853723)
Timeframe: 90 days

Carboxy-terminal Telopeptides of Collagen-1 (CTX)

(NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

Fractional Excretion of Calcium

(Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine) (NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

Procallagen-1 Amino-terminal Peptide (P1NP)

(NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

Serum Phosphorous

(NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

Total Serum Calcium (mg/dl)

(NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)

"Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP < or = 0.86 then TMP/GFR = TRP x P phos if TRP > 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos~U= urine, P = plasma" (NCT00853723)
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90

Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan

BMD was measured at the lumbosacral spine antero-posterior and at the femoral neck using a densitometer. A positive change from Baseline (increased bone density) indicates improvement. (NCT01400516)
Timeframe: Baseline and Month 12

Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. (NCT01400516)
Timeframe: Baseline and Month 12

Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan

Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement. (NCT01400516)
Timeframe: Baseline and Month 12

Reviews

46 reviews available for alendronate and Spinal Fractures

Trials

52 trials available for alendronate and Spinal Fractures

Other Studies

78 other studies available for alendronate and Spinal Fractures