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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00303485
Other study ID # ML19334
Secondary ID
Status Completed
Phase Phase 4
First received March 16, 2006
Last updated October 1, 2015
Start date February 2006
Est. completion date July 2007

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Placebo
po monthly for 6 months
Vitamin D and calcium supplementation
As prescribed
ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

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
See also
  Status Clinical Trial Phase
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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