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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00545363
Other study ID # ML19982
Secondary ID
Status Completed
Phase Phase 4
First received October 16, 2007
Last updated February 1, 2016
Start date May 2006
Est. completion date July 2008

Study information

Verified date February 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Slovenia: Agencija Republike Slovenije za zdravila in Medicinske Pripomocke
Study type Interventional

Clinical Trial Summary

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using serum CTX and communication of results at 3 months, on adherence to once monthly Bonviva (150mg po) in women with post-menopausal osteoporosis supported by PRP. Patients will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Recruitment information / eligibility

Status Completed
Enrollment 717
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria:

- ambulatory, post-menopausal women with osteoporosis;

- 55-85 years of age;

- eligible for bisphosphonate treatment;

- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake >= 6 months ago).

Exclusion Criteria:

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

- inability to swallow a tablet whole;

- hypersensitivity to bisphosphonates;

- treatment with drugs, or presence of active disease, known to influence bone metabolism;

- history of 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 6 months (+ feedback)
ibandronate [Bonviva/Boniva]
150mg po monthly for 6 months (- feedback)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Hungary,  Latvia,  Poland,  Romania,  Russian Federation,  Slovakia,  Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group 6 months No
Secondary Patient satisfaction by OPSAT-Q and OPPS 6 months No
Secondary Serum CTX levels 3 months No
Secondary AEs and laboratory parameters Throughout study No
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