Clinical trials: Bone Metabolism Disorders
Osteoporosis
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with…
- Trial name
- PEAK (NCT00365456)
- Testing
- Parathyroid Hormone (PTH), Risedronate
- Where
- Denmark
- Volunteers
- 407 people
- Sponsor
- Takeda
Osteoporosis
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage…
- Trial name
- NCT01833754
- Testing
- Romosozumab
- Where
- 5 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteopenia
A First-in-human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women
The primary objective of this study is to determine the safety and tolerability of AMG 167 following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.
- Trial name
- NCT00902356
- Testing
- AMG 167
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteopenia
A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of…
- Trial name
- NCT00950950
- Testing
- Romosozumab
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteoporosis
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in…
- Trial name
- NCT02106442
- Testing
- Sodium risedronate
- Where
- 2 sites in Japan
- Volunteers
- 579 people
- Sponsor
- Takeda
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Rhizomelic Chondrodysplasia Punctata
A First-in-Human Phase 1 Study of Plasmalogen Precursor PPI-1011 in Healthy Adult Volunteers to Assess Safety, Tolerability, and Pharmacokinetics
PPI-1011 is being developed as a docosahexaenoic acid (DHA) containing plasmalogen precursor with good long-term stability, specifically for the treatment of rhizomelic chondrodysplasia punctata (RCDP), which is an ultra rare…
- Trial name
- NCT05969977
- Testing
- PPI-1011
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- MED-LIFE DISCOVERIES LP
Postmenopausal Osteoporosis
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were…
- Trial name
- STRUCTURE (NCT01796301)
- Testing
- Romozosumab, Teriparatide
- Where
- 50 sites in United States, Argentina and 9 more
- Volunteers
- 436 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Study of Monthly Risedronate for Osteoporosis
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
- Trial name
- NCT00247273
- Testing
- risedronate
- Where
- 49 sites in United States, Argentina and 12 more
- Volunteers
- 1,294 people
- Sponsor
- Warner Chilcott
Postmenopausal Osteoporosis
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis.
- Trial name
- NCT00529373
- Testing
- Odanacatib, Vitamin D3, Calcium carbonate
- Volunteers
- 16,071 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
The Effect of Vitamin K2 on Bone Turnover
To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin.
- Trial name
- NCT00548509
- Testing
- Menatetrenone (Vitamin K2)
- Where
- 4 sites in Japan
- Volunteers
- 131 people
- Sponsor
- Eisai Limited
Postmenopausal Osteoporosis
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months.
- Trial name
- NCT00493532
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 14 sites in Taiwan
- Sponsor
- Hoffmann-La Roche
Osteoporosis, Postmenopausal, Back Pain
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.
- Conditions
- Osteoporosis, Postmenopausal, Back Pain, Spinal Fracture
- Trial name
- NCT00343252
- Testing
- teriparatide, risedronate
- Where
- 72 sites in United States, Argentina and 11 more
- Volunteers
- 712 people
- Sponsor
- Eli Lilly and Company
Osteoporosis
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures.
- Trial name
- NCT00051558
- Testing
- Teriparatide, Alendronate Sodium
- Where
- 15 sites in United States, Austria and 4 more
- Volunteers
- 428 people
- Sponsor
- Eli Lilly and Company
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Postmenopausal Women Osteoporosis
Post-menopausal Women Osteoporosis(Phase III)
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis
- Trial name
- NCT01806792
- Testing
- risedronate combine, Risedronate
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Thrombocytosis, Iron-Deficiency Anemia
Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)
The aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
- Trial name
- NCT00882414
- Testing
- FERINJECT® (Ferric carboxymaltose)
- Where
- Austria
- Volunteers
- 26 people
- Sponsor
- Vifor Pharma
Type 1 Diabetes Mellitus
Stem Cell Therapy for Type 1 Diabetes Mellitus
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
- Trial name
- NCT01143168
- Testing
- autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Cellonis Biotechnology Co. Ltd.
Breast Cancer, Osteoporosis
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
- Trial name
- NCT00767585
- Where
- Slovenia
- Volunteers
- 560 people
- Sponsor
- AstraZeneca