Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis (ROSE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Zoledronic acid 5 mg solution; Drug: Calcium/Vitamin D; Drug: Alendronate 70 mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404820

CZOL446HDE31

Details and patient eligibility

About

The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.

Enrollment: 604 patients

Sex: Female

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women

Exclusion criteria

• Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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604 participants in 2 patient groups

Zoledronic acid 5 mg

Experimental group

Description:

Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

Treatment:

Drug: Zoledronic acid 5 mg solution

Drug: Calcium/Vitamin D

Alendronate 70 mg

Active Comparator group

Description:

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

Treatment:

Drug: Alendronate 70 mg tablets

Drug: Calcium/Vitamin D