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Completed

NCT Number: NCT00371956

Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tuen Mun Hospital

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
  • Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).
  • Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.

Exclusion criteria

  • Patients with a history of thromboembolism.
  • Patients with positive antiphospholipid antibodies.
  • History of allergic reactions or intolerance to raloxifene or other SERMs.
  • Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
  • Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
  • Patients with abnormal uterine bleeding of unknown etiology.
  • Patients with serum creatinine level of >= 200 umol/L.

Treatment and study plan

Raloxifene

Drug

60mg/day

Placebo

Drug

tab 1 daily

Primary outcomes

  1. Bone turnover and bone mineral density

    Time frame: 12 months

Secondary outcomes

  1. Fracture, safety

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 4, 2006
Registry last updated
Sep 16, 2010

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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