MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

Roche

Status and phase: Completed; Phase 3

Conditions: Post Menopausal Osteoporosis

Treatments: Drug: Ibandronate [Bonviva/Boniva]; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048061

BM16549

Details and patient eligibility

About

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Enrollment: 1,609 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women 55-80 years of age;
• post-menopausal for >= 5 years;
• ambulatory.

Exclusion criteria

• malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
• breast cancer within the previous 20 years;
• allergy to bisphosphonates;
• previous treatment with an intravenous bisphosphonate at any time;
• previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,609 participants in 4 patient groups

Ibandronate 2.5 mg

Active Comparator group

Description:

Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .

Treatment:

Dietary Supplement: Vitamin D

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Dietary Supplement: Calcium

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Ibandronate 50/50 mg

Experimental group

Description:

Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.

Treatment:

Dietary Supplement: Vitamin D

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Dietary Supplement: Calcium

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Ibandronate 100 mg

Experimental group

Description:

Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day

Treatment:

Dietary Supplement: Vitamin D

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Dietary Supplement: Calcium

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Ibandronate 150 mg

Experimental group

Description:

Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day

Treatment:

Dietary Supplement: Vitamin D

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]

Dietary Supplement: Calcium

Drug: Ibandronate [Bonviva/Boniva]

Drug: Ibandronate [Bonviva/Boniva]