Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Comparison of Raloxifene and Strontium Ranelate on Compliance and Efficacy in Women With Postmenopausal Osteoporosis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01544894

Enrollment

Registered

2012-03-06

Start date

2009-09-30

Completion date

2011-10-31

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compliance, Postmenopausal Osteoporosis

Keywords

Postmenopausal osteoporosis, Compliance, Bone mineral density, Bonemarkers

Brief summary

The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.

Detailed description

OBJECTIVE: To compare the performance of raloxifene and strontium rannelate in the management of women with postmenopausal osteoporosis. DESIGN: Prospective, open label study. SETTING: University hospital menopause unit. PATIENTS: 80 women with postmenopausal osteoporosis were assigned to either raloxifene (60 mg/d) or strontium ranelate (2g/d). Participants were followed for 1 year. MAIN OUTCOME MEASURE(S): Compliance with each regime. Secondary objectives were parameters of efficacy, including changes in bone mineral density and bone biochemical markers.

Interventions

DRUGRaloxifene

60 mg/d for one year

DRUGStrontium ranelate

2 g/d, for one year

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Postmenopausal women with densitometric osteoporosis

Exclusion criteria

* Secondary osteoporosis

Design outcomes

Primary

Measure	Time frame	Description
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis	One year	Primary Outcome measure: compliance. Assessment of compliance assessed two variables, the number of participants maintaining treatment after one year and, among those that completed the one year treatment, the number of them that completed at least 80% of the prescribed dose.

Secondary

Measure	Time frame	Description
Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis	One year	Secondary outcome measure: efficacy. Efficacy has been assessed by changes in axial bone mineral density (spine and hip) and by changes in biochemical bone markers (C-telopeptides and P1NP in serum). Axial densitometry has been performed prior to treatment and after completion of the programmed one-year treatment. Bone markers have been assessed prior to treatment and at the 3rd, 6th and 12th month of treatment.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026