Clinical trials: Osteoporosis
Osteopenia, Osteoporosis
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who…
- Trial name
- NCT00523341
- Testing
- Denosumab
- Volunteers
- 4,550 people
- Sponsor
- Amgen
Osteoporosis
IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal…
- Trial name
- NCT00268632
- Testing
- risedronate
- Sponsor
- Sanofi
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
Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects
Primary objective of this study is to evaluate the similarity in pharmacokinetic characteristics between SAL023 Injection and Italy-manufactured Evenity.
- Trial name
- NCT07384104
- Testing
- SAL0123, Romosozumab
- Where
- China
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Fracture;Pelvis, Sacral Fracture
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture
- Trial name
- SAFFRON (NCT05426356)
- Testing
- Surgical Intervention, Non-Surgical Management
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- SI-BONE, Inc.
Osteoporosis
TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density
This is a placebo-controlled, single-ascending dose, multicenter Phase I clinical study to evaluate the safety, tolerability, PK and PD characteristics of a single intravenous infusion of TST002 in subjects with reduced bone…
- Trial name
- NCT05391776
- Testing
- TST002 Injection
- Where
- 5 sites in China
- Volunteers
- 32 people
- Sponsor
- HJB (Hangzhou) Co., Ltd.
Osteoporosis
Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)
The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of…
- Trial name
- NCT01803607
- Testing
- odanacatib
- Volunteers
- 135 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis
TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis
This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH [1-84]), on fracture incidence in women with…
- Trial name
- NCT00172081
- Testing
- ALX1-11
- Where
- 174 sites in United States, Argentina and 7 more
- Volunteers
- 2,532 people
- Sponsor
- Shire
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
Osteopenia, Osteoporosis
Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women
The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women.
- Trial name
- NCT00545116
- Testing
- Hesperidin
- Where
- Malaysia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Postmenopausal Osteoporosis
A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for…
- Trial name
- NCT05060406
- Testing
- LY06006
- Where
- China
- Volunteers
- 448 people
- Sponsor
- Luye Pharma Group Ltd.
Osteoporosis
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo.
- Trial name
- NCT01120600
- Testing
- Odanacatib, Vitamin D3, Calcium carbonate
- Volunteers
- 294 people
- Sponsor
- Merck Sharp & Dohme LLC
Postmenopausal Osteoporosis
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
This 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.
- Trial name
- NCT00545909
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 57 sites in Austria, Belgium and 3 more
- Volunteers
- 585 people
- Sponsor
- Hoffmann-La Roche
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
Post-Menopausal Osteoporosis
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP)…
- Trial name
- NCT03432533
- Testing
- romosozumab HCP administration with PFS, romosozumab self-administration with AI/Pen
- Where
- 46 sites in United States, Poland and 1 more
- Volunteers
- 283 people
- 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
Bone Mineral Density, Hemophilia A
Osteoporosis and MRI Study in Hemophilia
The purpose of this study is to evaluate bone mineral density in adult subjects with hemophilia versus a comparator population without hemophilia (non-hemophilia age- and gender-matched database) by using the following diagnostic…
- Conditions
- Bone Mineral Density, Hemophilia A, Hemophilia B
- Trial name
- NCT01460147
- Testing
- DXA scan + MRI
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Baxalta now part of Shire
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
Vertebral Compression Fracture
Investigating Bone Cement With or Without Inossia® Cement Softener for Vertebral Compression Fractures
The overall purpose of conducting this study is to evaluate the safety and efficacy of V-Flex and V-Steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a PMMA…
- Trial name
- SOFTBONE (NCT05676320)
- Testing
- V-Flex, V-Steady
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 203 people
- Sponsor
- Inossia AB