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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00545480
Other study ID # ML19358
Secondary ID
Status Completed
Phase Phase 4
First received October 16, 2007
Last updated August 17, 2015
Start date July 2006
Est. completion date March 2009

Study information

Verified date August 2015
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)
Study type Interventional

Clinical Trial Summary

This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Recruitment information / eligibility

Status Completed
Enrollment 596
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Female
Age group 55 Years and older
Eligibility Inclusion Criteria:

- ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;

- >55 years of age;

- naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months.

Exclusion Criteria:

- inability to stand or sit in an upright position for at least 60 minutes;

- hypersensitivity to bisphosphonates;

- treatment with other drugs affecting bone metabolism;

- history of major upper gastrointestinal disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (with feedback)
ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months (without feedback)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group 12 months No
Secondary Differences between groups in persistence 6 months No
Secondary QoL and patient satisfaction 6 and 12 months No
See also
  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 NCT00303485 - A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate) 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