Clinical trials: Osteoporosis
Osteoporosis
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.
- Trial name
- ACTIVATE (NCT00616694)
- Testing
- Actonel
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- Sanofi
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Low Bone Mineral Density
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD.
- Trial name
- NCT00043186
- Testing
- Denosumab, Alendronate
- Volunteers
- 412 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis, Postmenopause
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.
- Trial name
- NCT00381251
- Testing
- Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Osteoporosis
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.
- Trial name
- JADE (NCT00143273)
- Testing
- lasofoxifene
- Where
- 17 sites in Japan, South Korea and 1 more
- Volunteers
- 497 people
- Sponsor
- Ligand Pharmaceuticals
Osteoporosis, Postmenopausal
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
- Trial name
- MW031 (NCT04798313)
- Testing
- MW031, Prolia®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Osteoporosis
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.
- Trial name
- PEARL (NCT00141323)
- Testing
- lasofoxifene
- Where
- 201 sites in United States, Argentina and 30 more
- Volunteers
- 8,556 people
- Sponsor
- Ligand Pharmaceuticals
Osteoporosis
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
- Trial name
- NCT00769418
- Testing
- odanacatib
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis, Postmenopausal Osteoporosis
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
- Trial name
- ACTIVE (NCT01343004)
- Testing
- BA058 80 mcg, teriparatide
- Where
- 28 sites in United States, Argentina and 8 more
- Volunteers
- 2,463 people
- Sponsor
- Radius Health, Inc.
Osteoporosis, Postmenopausal
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in…
- Trial name
- ALVOBOND (NCT05395091)
- Testing
- AVT03, Denosumab
- Where
- 34 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 532 people
- Sponsor
- Alvotech Swiss AG
Low Bone Mass, Low Bone Mineral Density
A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
- Trial name
- NCT00887965
- Testing
- Previous denosumab
- Volunteers
- 15 people
- Sponsor
- Amgen
Osteoporosis
HDDO-1614 Intervention Trial
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
- Trial name
- NCT03234244
- Testing
- Bazedoxifene 20 mg, Cholecalciferol, Bazedoxifene 20mg and Cholecalciferol
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Postmenopausal Osteoporosis
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this…
- Trial name
- NCT00091793
- Testing
- AMG 162
- Volunteers
- 332 people
- Sponsor
- Amgen
Osteoporosis
Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
- Trial name
- NCT04936984
- Testing
- abaloparatide-sMTS (Patheon), abaloparatide-sMTS (Kindeva)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Radius Health, Inc.
Postmenopausal Osteoporosis
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
- Trial name
- NCT02016716
- Testing
- Romosozumab 90 mg/mL, Romosozumab 70 mg/mL
- Where
- 12 sites in United States, Czechia and 1 more
- Volunteers
- 294 people
- Sponsor
- Amgen
Back Pain
The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
- Trial name
- NCT00713258
- Testing
- Parathyroid hormone (PTH) (1-84), Alendronate
- Where
- Denmark
- Volunteers
- 75 people
- Sponsor
- Nycomed
Osteoporosis
A Comparison of PF708 and Forteo in Osteoporosis Patients
The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
- Trial name
- NCT03002428
- Testing
- Teriparatide (PF708), Teriparatide (Forteo)
- Where
- 26 sites in United States
- Volunteers
- 181 people
- Sponsor
- Pfenex, Inc
Postmenopausal Osteoporosis
Open-label Study to Evaluate the Effect of MBP-80 on Bone Remodelling
This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women.
- Trial name
- YogA (NCT01501344)
- Testing
- 200 g yogurt with fortified calcium content and MBP 80 mg
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
Osteoporosis
A Study of LY2541546 in Women With Low Bone Mineral Density
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546…
- Trial name
- NCT01144377
- Testing
- LY2541546
- Where
- 8 sites in United States, Denmark and 3 more
- Volunteers
- 154 people
- Sponsor
- Eli Lilly and Company
Osteoporosis
A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)
The purpose of this study was to identify an appropriate dose of MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.
- Trial name
- NCT00960934
- Testing
- MK-5442, Vitamin D3, Calcium carbonate
- Volunteers
- 383 people
- Sponsor
- Merck Sharp & Dohme LLC