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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Menopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ibandronate

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.

Group Type EXPERIMENTAL

Vitamin D and calcium supplementation

Intervention Type DRUG

As prescribed

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

150mg po monthly for 6 months

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po monthly for 6 months

Vitamin D and calcium supplementation

Intervention Type DRUG

As prescribed

Interventions

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Placebo

po monthly for 6 months

Intervention Type DRUG

Vitamin D and calcium supplementation

As prescribed

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 6 months

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes