Clinical trials: Bone Metabolism Disorders
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
Postmenopausal Women With Osteoporosis
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
- Trial name
- ARCH (NCT01631214)
- Testing
- Romosozumab, Alendronate
- Where
- 316 sites in United States, Argentina and 40 more
- Volunteers
- 4,093 people
- Sponsor
- Amgen
Osteoporosis, Atypical Femoral Fracture
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral…
- Trial name
- FiX-IT (NCT01705587)
- Testing
- teriparatide
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Susan L. Greenspan
Post-Menopausal Osteoporosis
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550…
- Trial name
- NCT00551174
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 39 sites in United States, Australia and 13 more
- Volunteers
- 781 people
- Sponsor
- Hoffmann-La Roche
Osteoporosis
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton.
- Trial name
- NCT00259298
- Testing
- teriparatide
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes Mellitus
Islet Cell Transplantation Alone and CD34+ Donor Bone Marrow Cell Infusion in Type 1 Diabetes Mellitus
SPECIFIC AIMS: To reverse hyperglycemia and insulin dependency in patients with Type 1 diabetes mellitus by islet cell transplantation.
- Trial name
- NCT00315614
- Testing
- Islet Transplantation and Bone Marrow
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Miami
Hypophosphatasia (HPP)
A Retrospective Study of the Natural History of Patients With Severe Perinatal and Infantile Hypophosphatasia (HPP)
This study aims to characterize the natural history of patients with severe perinatal or infantile onset HPP.
- Trial name
- NCT01419028
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 48 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Iron Overload Due to Transfusion-dependant Anemias
Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)
Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance
- Trial name
- NCT02125877
- Testing
- Deferasirox dispersible tablet, Defearisox film-coated tablet
- Where
- 51 sites in United States, Argentina and 14 more
- Volunteers
- 173 people
- Sponsor
- Novartis Pharmaceuticals
Hypophosphatemia, Familial, Hyperparathyroidism
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets
The purpose of this study is to determine the effectiveness of paricalcitol, a form of synthetic vitamin D, in lowering parathyroid hormone (PTH) levels and reducing disease symptoms in children and adults with X-linked…
- Trial name
- NCT00417612
- Testing
- Paricalcitol
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Yale University
Hypophosphatasia (HPP)
Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)
The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.
- Trial name
- NCT02104219
- Where
- 19 sites in United States, Australia and 6 more
- Volunteers
- 32 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic…
- Trial name
- SOTA-BONE (NCT03386344)
- Testing
- Sotagliflozin
- Where
- 53 sites in United States, Australia and 6 more
- Volunteers
- 376 people
- Sponsor
- Lexicon Pharmaceuticals
Menopause, Osteoporosis
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal…
- Trial name
- NCT00808132
- Testing
- bazedoxifene 20 mg/ conjugated estrogens 0.45 mg, bazedoxifene 20 mg/ conjugated estrogens 0.625 mg, bazedoxifene 20 mg
- Where
- 178 sites in United States, Argentina and 10 more
- Volunteers
- 1,886 people
- Sponsor
- Pfizer
Bone; Disorder, Development and Growth
Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
This study will determine whether the negative effects of combined oral contraceptive (COC) therapy on the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis and bone turnover are dependent on the route of administration…
- Trial name
- NCT02367833
- Testing
- Combined Oral Contraceptive, Transdermal Contraceptive, Contraceptive Vaginal Ring
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Penn State University
Hypophosphatasia
Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone.
- Trial name
- NCT01163149
- Testing
- asfotase alfa
- Where
- 3 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Postmenopausal Osteoporosis
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.
- Trial name
- NCT01321723
- Testing
- PTH analog, Forsteo (Teriparatide)
- Where
- 4 sites in Denmark, Estonia
- Volunteers
- 97 people
- Sponsor
- Unigene Laboratories Inc.
Osteoporotic Fractures, Osteoporosis, Postmenopausal
A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women
This proposed study was designed to investigate the prevalence of a 5-year incident osteoporotic fracture and evaluate the association of a 5-year change of 25-hydroxyvitamin D (25[OH]D)/bone turnover makers/bone mineral density…
- Trial name
- PK-VF (NCT02247011)
- Testing
- Questionaire survey, Bone mineral density examination, Vertebral fracture assessment
- Where
- China
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
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
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals
Osteoporosis
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D…
- Trial name
- NCT00806416
- Testing
- alendronate sodium (+) cholecalciferol, Comparator: alendronate, Comparator: cholecalciferol (Vitamin D)
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Osteoporosis, Multiple Sclerosis
Zoledronic Acid in MS-patients With Osteoporosis
This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis and to support the optimal use of zoledronic acid for…
- Trial name
- EXALT (NCT01166178)
- Testing
- Zoledronic Acid, Calcium and Vitamin D combination
- Where
- 15 sites in Germany
- Volunteers
- 29 people
- Sponsor
- Novartis