Clinical trials: Postmenopausal Osteopenia
Postmenopausal Osteoporosis
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
- Trial name
- NCT04366726
- Testing
- abaloparatide-sMTS
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Radius Health, Inc.
Postmenopausal, Osteopenia
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone…
- Trial name
- NCT01825785
- Testing
- Romosozumab
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia
This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or…
- Trial name
- NCT02604836
- Testing
- Ibandronate
- Where
- 142 sites in United States
- Volunteers
- 1,711 people
- Sponsor
- Hoffmann-La Roche
Osteopenia, Osteoporosis
Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
- Trial name
- NCT00577850
- Testing
- risedronate, alendronate
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Warner Chilcott
Osteopenia
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
- Trial name
- NCT00386360
- Testing
- risedronate
- Where
- 9 sites in Argentina, Australia and 5 more
- Volunteers
- 161 people
- Sponsor
- Warner Chilcott
Postmenopausal Osteoporosis
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
- Trial name
- NCT00293813
- Testing
- Alendronate, Denosumab
- Volunteers
- 247 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
- Trial name
- NCT04064411
- Testing
- abaloparatide, abaloparatide solid microstructured transdermal system
- Where
- 97 sites in United States, Denmark and 3 more
- Volunteers
- 511 people
- Sponsor
- Radius Health, Inc.
Postmenopausal
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly…
- Trial name
- NCT00577837
- Testing
- risedronate, experimental
- Where
- 14 sites in United States, Canada and 3 more
- Volunteers
- 370 people
- Sponsor
- Warner Chilcott
Osteoporosis
Denosumab Adherence Preference Satisfaction Study
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12…
- Trial name
- NCT00518531
- Testing
- alendronate, denosumab
- Volunteers
- 250 people
- Sponsor
- Amgen
Osteopenia
An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density
The purpose of this study is to assess the safety, tolerability, and potential immune response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose administrations in healthy men and postmenopausal women…
- Trial name
- NCT01101048
- Testing
- AMG 167
- Volunteers
- 74 people
- Sponsor
- Amgen
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
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
Breast Cancer
The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every…
- Trial name
- NCT00171314
- Testing
- Zoledronic acid, Letrozole
- Where
- 49 sites in Argentina, Belgium and 7 more
- Volunteers
- 527 people
- Sponsor
- Novartis Pharmaceuticals
OSTEOPOROSIS, POSTMENOPAUSAL
Risedronate in Postmenopausal Women With Low Bone Density
The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen…
- Trial name
- NCT00351091
- Testing
- RISEDRONATE
- Volunteers
- 150 people
- Sponsor
- Sanofi
Postmenopausal Osteoporosis
Study of Transitioning From Alendronate to Denosumab
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab.
- Trial name
- NCT00377819
- Testing
- alendronate, Denosumab (AMG 162)
- Volunteers
- 504 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).
- Trial name
- ACTIVExtend (NCT01657162)
- Testing
- Alendronate
- Where
- 25 sites in United States, Argentina and 8 more
- Volunteers
- 1,139 people
- Sponsor
- Radius Health, Inc.
Bone Loss, Osteoporosis
Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women
Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women.
- Trial name
- NCT01159873
- Testing
- CEP-37251
- Where
- Australia
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Cephalon
Breast Cancer
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles.
- Trial name
- SABRE (NCT00082277)
- Testing
- Anastrozole, Risedronate Sodium
- Where
- 35 sites in United States, Canada and 6 more
- Volunteers
- 237 people
- Sponsor
- AstraZeneca
Osteopenia
A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture.
- Trial name
- NCT01292187
- Testing
- Oral calcitonin at dinnertime, Oral calcitonin at bedtime
- Where
- 10 sites in United States
- Volunteers
- 129 people
- Sponsor
- Tarsa Therapeutics, Inc.
Low Bone Mineral Density, Postmenopausal Osteoporosis
Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low…
- Trial name
- NCT00896532
- Testing
- Alendronate, Teriparatide, Romosozumab
- Volunteers
- 419 people
- Sponsor
- Amgen