A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

Roche

Status and phase: Completed; Phase 4

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: Vitamin D and calcium supplementation; Drug: Placebo; Drug: ibandronate [Bonviva/Boniva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00303485

ML19334

Details and patient eligibility

About

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 approximately 7 months, and the target sample size is <100 individuals.

Enrollment: 67 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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 hormone replacement therapy (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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

Ibandronate

Experimental group

Description:

Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.

Treatment:

Drug: Vitamin D and calcium supplementation

Drug: ibandronate [Bonviva/Boniva]

Placebo

Placebo Comparator group

Description:

Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.

Treatment:

Drug: Vitamin D and calcium supplementation

Drug: Placebo