An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal...
Postmenopausal OsteoporosisThe primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of...
OsteoporosisPostmenopausalThe purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis...
Postmenopausal OsteoporosisThe purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)...
Osteoporosis PostmenopausalThe purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants. The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With...
OsteoporosisPostmenopausalTo study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis....
Postmenopausal OsteoporosisThis 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With...
Post-Menopausal OsteoporosisThis 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal...
Postmenopausal OsteoporosisThis 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
OsteoporosisPostmenopausalThis study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5 years, in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover.
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women...
OsteoporosisPost-menopausalThe purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.