Conditions: Post Menopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 67
Healthy volunteers: yes

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

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Placebo intervention 2: Vitamin D and calcium supplementation intervention 3: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: po monthly for 6 months intervention 2: As prescribed intervention 3: 150mg po monthly for 6 months

Protocol document: