Clinical trials: Metabolic Bone Disease
Osteopenia, Osteoporosis
Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults
The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation.
- Conditions
- Osteopenia, Osteoporosis, Menopause Related Conditions, Probiotic Intervention
- Trial name
- NCT07538167
- Testing
- SBD111(current formulation), SBD111 (new formulation)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Solarea Bio, Inc
Iron Overload
Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia
The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with Iron Overload and Aplastic Anemia.
- Trial name
- NCT01546415
- Testing
- Desferasirox
- Where
- 7 sites in China
- Volunteers
- 64 people
- Sponsor
- Novartis Pharmaceuticals
Osteoporosis
Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label…
- Trial name
- e-GLORIA (NCT01974167)
- Testing
- Eldecalcitol, Alfacalcidol
- Where
- Japan
- Volunteers
- 400 people
- Sponsor
- e-GLORIA trial Protocol Review Committee
Breast Neoplasms, Osteoporosis
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip…
- Trial name
- NCT00050011
- Testing
- Zoledronic Acid, Letrozole
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 602 people
- Sponsor
- Novartis Pharmaceuticals
Osteoporosis
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.
- Trial name
- NCT00100607
- Testing
- AAE581
- Volunteers
- 676 people
- Sponsor
- Novartis Pharmaceuticals
Osteoporosis
A Dose-response Study With Strontium Malonate in Postmenopausal Women
The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.
- Trial name
- NCT00409032
- Testing
- Strontium malonate
- Where
- 9 sites in Denmark, United Kingdom
- Volunteers
- 275 people
- Sponsor
- Osteologix
Amyotrophic Lateral Sclerosis
Safety/Efficacy Study for the Treatment of Amyotrophic Lateral Sclerosis
A Phase I, single center, prospective, non-randomized, open label, safety/efficacy study of the infusion of autologous bone marrow-derived stem cells, in 6 patients with Amyotrophic Lateral Sclerosis according to established…
- Trial name
- ALS (NCT01082653)
- Testing
- autologous bone marrow-derived stem cells
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- TCA Cellular Therapy
Osteoporosis
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
- Trial name
- NCT00641771
- Testing
- alendronate sodium (+) cholecalciferol
- Volunteers
- 56 people
- Sponsor
- Organon and Co
Fall, Fall Patients
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of…
- Conditions
- Fall, Fall Patients, Osteoporosis
- Trial name
- FAIR (NCT05155761)
- Testing
- FeetMe® Monitor
- Where
- France
- Volunteers
- 250 people
- Sponsor
- FeetMe
Osteoporosis
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in…
- Trial name
- NCT05067335
- Testing
- Romosozumab
- Where
- 30 sites in China
- Volunteers
- 327 people
- Sponsor
- UCB Biopharma SRL
Post Menopausal Osteoporosis
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
- Trial name
- PILOTE (NCT02347865)
- Testing
- AMG 162 - Prolia
- Where
- France
- Volunteers
- 777 people
- Sponsor
- Amgen
Osteoporosis
Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)
Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women.
- Trial name
- LIFT (NCT00519857)
- Testing
- Tibolone
- Volunteers
- 4,534 people
- Sponsor
- Organon and Co
Fanconi Anemia
Long-Term Follow-up: Phase I/II Clinical Study to Evaluate the Safety and Efficacy of the Infusion of RP-L102
Long-Term Follow-up: Phase I/II clinical study to evaluate the safety and efficacy of the infusion of RP-L102
- Trial name
- NCT07527975
- Testing
- RP-L102
- Where
- 3 sites in United States, Spain and 1 more
- Volunteers
- 14 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Gaucher Disease
A Study Measuring Substances Potentially Indicating Bone Problems in Adults With Type 1 Gaucher Condition
Substances in the body, so-called biomarkers, can help predict the severity of Gaucher disease (GD)-related bone problems in adults.
- Trial name
- NCT05702814
- Testing
- No Intervention
- Where
- Spain
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Takeda
Osteoporosis, Postmenopausal, Bone Density, Low
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures.
- Trial name
- NCT06375668
- Testing
- Probiotic
- Where
- 3 sites in Poland
- Volunteers
- 170 people
- Sponsor
- Nordic Biotic Sp. z o.o.
Osteoporosis, Postmenopausal
Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General…
- Trial name
- NCT05419427
- Testing
- Denosumab, Denosumab-Ref
- Where
- India
- Volunteers
- 552 people
- Sponsor
- Lambda Therapeutic Research Ltd.
Psoriatic Arthritis, Overweight or Obesity
A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)
The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related…
- Trial name
- NCT06864026
- Testing
- Tirzepatide
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
- Trial name
- NCT01785875
- Testing
- Etelcalcetide
- Where
- 208 sites in United States, Australia and 15 more
- Volunteers
- 891 people
- Sponsor
- Amgen
Osteoporosis
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
- Trial name
- BILANZ (NCT01512446)
- Testing
- Alendronate
- Where
- Germany
- Volunteers
- 436 people
- Sponsor
- Evangelisches Krankenhaus Lutherhaus gGmbH
Osteoporosis, Postmenopausal
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in…
- Trial name
- ALVOBOND (NCT05395091)
- Testing
- AVT03, Denosumab
- Where
- 34 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 532 people
- Sponsor
- Alvotech Swiss AG