Post Menopausal Osteoporosis Clinical Trial
Official title:
A Randomized Double-blind Study to Determine the Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once-monthly Boniva (Ibandronate) Versus Placebo in the Treatment of Post-menopausal Osteoporosis
Verified date | October 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Status | Completed |
Enrollment | 67 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment; - naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening. Exclusion Criteria: - patients on HRT within the last 3 months; - patients on other osteoporosis medication within the last 3 months; - sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level; - hypersensitivity to any component of ibandronate; - contraindication for calcium or vitamin D therapy; - history of major gastrointestinal upset; - malignant disease diagnosed within the previous 10 years (except resected basal cell cancer). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients whose sCTX concentration decreases by >=8%. | Day 3 | No | |
Secondary | Percentage of patients whose sCTX concentration decreases by >=8% | Throughout study | No | |
Secondary | Change in BSAP | Throughout study | No | |
Secondary | Change in PTH | Month 1 Day 7, and Month 6 Day 7. | No | |
Secondary | AEs and laboratory parameters | Throughout study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01674621 -
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
|
Phase 2 | |
Completed |
NCT01732770 -
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
|
Phase 4 | |
Completed |
NCT00377234 -
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
|
Phase 4 | |
Recruiting |
NCT05571514 -
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
|
N/A | |
Completed |
NCT00048074 -
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
|
Phase 3 | |
Completed |
NCT02347865 -
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
|
||
Completed |
NCT00545480 -
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
|
Phase 4 | |
Active, not recruiting |
NCT05332626 -
Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women
|
N/A | |
Completed |
NCT00545090 -
ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
|
Phase 4 | |
Completed |
NCT02598934 -
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
|
Phase 4 | |
Completed |
NCT01290094 -
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
|
Phase 3 | |
Completed |
NCT00048061 -
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
|
Phase 3 |