Clinical trials: Osteoporosis Postmenopausal
Postmenopausal Women With Osteoporosis
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and…
- Trial name
- NCT03974100
- Testing
- GP2411, EU-Prolia (EU-authorized Prolia®)
- Where
- 42 sites in United States, Bulgaria and 4 more
- Volunteers
- 527 people
- Sponsor
- Sandoz
Osteoporosis, Postmenopausal
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be…
- Trial name
- TOP (NCT01381588)
- Testing
- Fracture evaluation
- Where
- South Korea
- Volunteers
- 1,136 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Postmenopausal Women With Osteoporosis
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.
- Trial name
- NCT06898060
- Testing
- QLG2128, Teriparatide Injection
- Volunteers
- 282 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Osteoporosis, Postmenopausal
OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide…
- Trial name
- NCT00130403
- Testing
- risedronate sodium
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 290 people
- Sponsor
- Sanofi
Postmenopausal Osteoporosis With Pathological Fracture
Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo
The primary objective of this study is to compare efficacy and safety of two formulations of teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.
- Trial name
- NCT01945788
- Testing
- Teriparatide (rDNA origin)
- Where
- Argentina
- Volunteers
- 110 people
- Sponsor
- Bio Sidus SA
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
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid
1. The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service.
- Trial name
- LISA (NCT00745485)
- Testing
- zoledronic acid
- Where
- 14 sites in Australia
- Volunteers
- 186 people
- Sponsor
- Novartis Pharmaceuticals
Osteoporosis
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.
- Trial name
- NCT00709540
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Low Bone Mineral Density, Osteopenia
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).
- Conditions
- Low Bone Mineral Density, Osteopenia, Osteoporosis
- Trial name
- NCT00515463
- Testing
- denosumab
- Volunteers
- 311 people
- Sponsor
- Amgen
Osteoporosis
Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.
- Trial name
- NCT00431444
- Testing
- Raloxifene, Zoledronic acid
- Where
- 17 sites in United States
- Volunteers
- 110 people
- Sponsor
- Novartis
Osteoporosis
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.
- Trial name
- ROSE (NCT00404820)
- Testing
- Zoledronic acid 5 mg solution, Alendronate 70 mg tablets, Calcium/Vitamin D
- Where
- Germany
- Volunteers
- 604 people
- Sponsor
- Novartis
Osteoporosis Postmenopausal
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with…
- Trial name
- NCT00358176
- Testing
- Risedronate (HMR4003)
- Where
- 11 sites in United States, Argentina and 9 more
- Volunteers
- 1,231 people
- Sponsor
- Sanofi
Osteoporosis
A Phase I Study of AK159 in Healthy Postmenopausal Women
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
- Trial name
- NCT01935479
- Testing
- AK159, MN-10-T
- Where
- 3 sites in Japan
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Asahi Kasei Therapeutics Corporation
Osteoporosis, Postmenopausal, Osteoporosis
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk
- Trial name
- NCT03710889
- Testing
- Abaloparatide
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Radius Health, Inc.
Osteoporosis
Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)
This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density.
- Trial name
- NCT00729183
- Testing
- Odanacatib, Vitamin D3, Calcium supplement
- Volunteers
- 214 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis
Safety and Tolerability of Odanacatib (0822-059)
This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib
- Trial name
- NCT01068262
- Testing
- Odanacatib
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis, Postmenopausal
Denosumab China Phase III Study
This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.
- Trial name
- NCT02014467
- Testing
- Denosumab, Elemental Calcium, Vitamin D
- Where
- 8 sites in China
- Volunteers
- 486 people
- Sponsor
- GlaxoSmithKline
Osteoporosis, Postmenopausal
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT).
- Trial name
- NCT00398931
- Testing
- MK0217, alendronate sodium / Duration of Treatment : 5 Years
- Volunteers
- 1,099 people
- Sponsor
- Organon and Co
Osteoporosis, Postmenopausal
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis.
- Trial name
- JULINA-CLIMA (NCT01386281)
- Testing
- E2 transdermal (Julina, BAY86-5435)
- Where
- Japan
- Volunteers
- 506 people
- Sponsor
- Bayer
Postmenopausal
A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture
This is a randomized, double-blind, international multicentre, parallel-controlled phase III clinical study. The study plans to enroll 478 postmenopausal women with osteoporosis at high risk of fracture, whom will be randomized…
- Trial name
- NCT05352516
- Testing
- HLX14, Prolia®
- Where
- 38 sites in China
- Volunteers
- 514 people
- Sponsor
- Shanghai Henlius Biotech