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Completed

NCT Number: NCT01544894

Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

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

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Key information

Conditions

Postmenopausal Osteoporosis Behavior Bone Diseases Bone Diseases, Metabolic Compliance Health Behavior Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Dr Peset

Valencia, 46017, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women with densitometric osteoporosis

Exclusion criteria

  • Secondary osteoporosis

Treatment and study plan

Raloxifene

Drug

60 mg/d for one year

Other names: Evista

Strontium Ranelate

Drug

2 g/d, for one year

Other names: Protelos

Primary outcomes

  1. Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis

    Time frame: 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 outcomes

  1. Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2012
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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