Clinical trials: Osteoporosis
Osteoporosis
An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol
This study examines quality of life and patient satisfaction in postmenopausal women receiving raloxifene to prevent/treat osteoporosis, and vitamin D to reduce risk of fracture using clinical practice data.
- Trial name
- NCT04788290
- Testing
- Observational
- Where
- South Korea
- Volunteers
- 3,907 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Osteoporosis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
- Trial name
- NCT03822078
- Testing
- Denosumab
- Volunteers
- 45 people
- Sponsor
- Amgen
Back Pain
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF)…
- Trial name
- NCT00771758
- Testing
- oxycodone IR, tapentadol IR
- Where
- 37 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Osteoporosis
Open Label Extension Study of PREOS
This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human…
- Trial name
- OLES (NCT00172133)
- Testing
- ALX1-11 (drug)
- Where
- 132 sites in United States, Argentina and 6 more
- Volunteers
- 1,683 people
- Sponsor
- Shire
Osteoporosis
A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis
A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone [rhPTH(1-84)])(50, 75 and 100 µg) in the treatment of postmenopausal…
- Trial name
- NCT00172107
- Testing
- ALX1-11 50 mcg, ALX1-11 75mcg, ALX1-11
- Where
- 19 sites in United States, Canada
- Volunteers
- 217 people
- Sponsor
- Shire
Osteoporosis
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
- Trial name
- DIRECT (NCT00680953)
- Testing
- Denosumab, Alendronate sodium hydrate
- Where
- 4 sites in Japan
- Volunteers
- 1,262 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Postmenopausal Osteoporosis, Low Bone Mass
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone…
- Trial name
- NCT07806331
- Testing
- Denosumab
- Volunteers
- 110 people
- Sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
Postmenopause, Osteoporosis
PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)
The objectives of the study are to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire) pain assessment at the beginning of the Preotact®…
- Trial name
- NCT00515593
- Testing
- Parathyroid hormone (PTH) (Preotact)
- Where
- Germany
- Volunteers
- 110 people
- Sponsor
- Nycomed
Osteoporosis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
- Trial name
- NCT05930704
- Testing
- SHR-2017 injection
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Osteoporosis
Upper GI Handling of Branded vs. Generic Alendronate
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.
- Trial name
- NCT00400530
- Testing
- MK0217, alendronate sodium / Duration of Treatment: 1 Month, Comparator: Alendronate-Teva / Duration of Treatment: 1 Month
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis
Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women
The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
- Trial name
- NCT00481169
- Testing
- Bazedoxifene Acetate (TSE-424)
- Volunteers
- 1,742 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
The purpose of this trial is to study: Effects of arzoxifene on bone fractures and bone mass. Effects of arzoxifene on getting breast cancer.
- Trial name
- NCT00088010
- Testing
- Arzoxifene
- Where
- United States
- Volunteers
- 9,369 people
- Sponsor
- Eli Lilly and Company
Fragility Fracture, Hip Fractures
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures.
- Conditions
- Fragility Fracture, Hip Fractures, Osteoporosis
- Trial name
- NCT04796350
- Testing
- AGN1 LOEP treatment
- Where
- 66 sites in Austria, Belgium and 9 more
- Volunteers
- 2,400 people
- Sponsor
- AgNovos Healthcare, LLC
Osteoporosis
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
- Trial name
- CORAL (NCT00163137)
- Testing
- lasofoxifene, raloxifene
- Where
- 72 sites in United States
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Ligand Pharmaceuticals
Osteoporosis
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip.
- Trial name
- NCT00752557
- Testing
- rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy), bisphosphonates, calcium, and vitamin D
- Where
- 35 sites in United States, Belgium and 2 more
- Volunteers
- 50 people
- Sponsor
- Pfizer
Osteoporosis
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis
This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.
- Trial name
- NCT06154187
- Testing
- PBK_L2201
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Pharmbio Korea Co., Ltd.
Osteoporosis, Postmenopausal
A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)
This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.
- Trial name
- NCT01350934
- Testing
- alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus), Calcitriol, Calcium 500 mg
- Volunteers
- 219 people
- Sponsor
- Organon and Co
Postmenopausal Osteoporosis
Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis
This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.
- Trial name
- NCT05278338
- Testing
- JMT103, Denosumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai JMT-Bio Inc.
Osteoporosis, Postmenopausal
Julina Post-marketing Surveillance for Postmenopausal Osteoporosis 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
- NCT01397955
- Testing
- E2 transdermal (Julina, BAY86-5435)
- Where
- Japan
- Volunteers
- 148 people
- Sponsor
- Bayer