cholecalciferol and odanacatib

cholecalciferol has been researched along with odanacatib* in 1 studies

Trials

1 trial(s) available for cholecalciferol and odanacatib

Article	Year
Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. The Journal of clinical endocrinology and metabolism, 2013, Volume: 98, Issue:12 Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.. The effects of ODN were evaluated on bone mineral density (BMD), biochemical markers of bone turnover, and safety in patients previously treated with alendronate.. This was a randomized, double-blind, placebo-controlled, 24-month study.. The study was conducted at private or institutional practices.. Postmenopausal women (n = 243) ≥ 60 years of age with low BMD at the total hip, femoral neck, or trochanter (T-score ≤-2.5 but >-3.5 without prior fracture or ≤-1.5 but >-3.5 with prior fracture) on alendronate for ≥ 3 years.. The intervention included ODN 50 mg or placebo weekly.. The primary end point was percentage change from baseline of femoral neck BMD at month 24. BMD was assessed by dual-energy x-ray absorptiometry at baseline and 6, 12, and 24 months. Biochemical markers of bone turnover (serum C-telopeptides of type 1 collagen, urinary N-telopeptides of type 1 collagen, serum bone specific alkaline phosphatase, and serum N-terminal propeptide of type 1 collagen) were measured at baseline and 3, 6, 12, 18, and 24 months.. In the ODN group, BMD changes from baseline at the femoral neck, trochanter, total hip, and lumbar spine at 24 months (1.7%, 1.8%, 0.8%, and 2.3%, respectively) were significantly different from the placebo group. ODN significantly decreased urinary N-telopeptides of type 1 collagen to creatinine ratio and significantly increased serum N-terminal propeptide of type 1 collagen compared with placebo. Serum C-telopeptides of type 1 collagen was unexpectedly increased with ODN treatment. The safety profile appeared similar between groups.. ODN provided incremental BMD gains in osteoporotic women after alendronate treatment. Topics: Aged; Alendronate; Biomarkers; Biphenyl Compounds; Bone and Bones; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Calcium, Dietary; Cathepsin K; Cholecalciferol; Combined Modality Therapy; Dietary Supplements; Double-Blind Method; Drug Monitoring; Female; Humans; Medication Adherence; Middle Aged; Osteoporosis, Postmenopausal; Patient Dropouts; Protease Inhibitors	2013

Article

Year

Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial.

The Journal of clinical endocrinology and metabolism, 2013, Volume: 98, Issue:12

Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.. The effects of ODN were evaluated on bone mineral density (BMD), biochemical markers of bone turnover, and safety in patients previously treated with alendronate.. This was a randomized, double-blind, placebo-controlled, 24-month study.. The study was conducted at private or institutional practices.. Postmenopausal women (n = 243) ≥ 60 years of age with low BMD at the total hip, femoral neck, or trochanter (T-score ≤-2.5 but >-3.5 without prior fracture or ≤-1.5 but >-3.5 with prior fracture) on alendronate for ≥ 3 years.. The intervention included ODN 50 mg or placebo weekly.. The primary end point was percentage change from baseline of femoral neck BMD at month 24. BMD was assessed by dual-energy x-ray absorptiometry at baseline and 6, 12, and 24 months. Biochemical markers of bone turnover (serum C-telopeptides of type 1 collagen, urinary N-telopeptides of type 1 collagen, serum bone specific alkaline phosphatase, and serum N-terminal propeptide of type 1 collagen) were measured at baseline and 3, 6, 12, 18, and 24 months.. In the ODN group, BMD changes from baseline at the femoral neck, trochanter, total hip, and lumbar spine at 24 months (1.7%, 1.8%, 0.8%, and 2.3%, respectively) were significantly different from the placebo group. ODN significantly decreased urinary N-telopeptides of type 1 collagen to creatinine ratio and significantly increased serum N-terminal propeptide of type 1 collagen compared with placebo. Serum C-telopeptides of type 1 collagen was unexpectedly increased with ODN treatment. The safety profile appeared similar between groups.. ODN provided incremental BMD gains in osteoporotic women after alendronate treatment.

Topics: Aged; Alendronate; Biomarkers; Biphenyl Compounds; Bone and Bones; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Calcium, Dietary; Cathepsin K; Cholecalciferol; Combined Modality Therapy; Dietary Supplements; Double-Blind Method; Drug Monitoring; Female; Humans; Medication Adherence; Middle Aged; Osteoporosis, Postmenopausal; Patient Dropouts; Protease Inhibitors

2013