Prospective clinical study of once monthly ibandronate in the treatment of osteoporosis and prevention of fractures in postmenopausal women: ORPHEUM Study

Srp Arh Celok Lek. 2011 Nov-Dec;139(11-12):790-4.

Abstract

Introduction: Osteoporosis is a serious problem, since about 50% of women over the age of 50 suffer at least one osteoporotic fracture.

Objective: The aim of this study was to evaluate compliance as well as the efficiency and safety of ibandronate treatment over a 6-month period in reducing the risk of subsequent fracture in women with postmenopausal osteoporosis.

Methods: A multicenter, prospective, observational study was conducted during one year in thirteen medical centres in Serbia. In the first part of the study the participants received ibandronate tablets (150 mg) once a month for six months. In the second part, the patients were under clinical follow-up.

Results: The mean age of the 184 menopausal women included in the study was 66.2 +/- 9.4 years. In 40.2% of the subjects the disease had been clinically manifest during the five preceding years. The mean T-score value at the onset of our investigation was -3.1 +/- 0.84 in 160 (87%) patients who were diagnosed osteoporosis. Compression vertebral fractures alone were noted in 24% of the women, spontaneous nonvertebral fractures in 49.4% and both in 4.9%. A history of osteoporotic fractures was much more common in patients with three or four risk factors (p = 0.001). Out of 39 adverse events during therapy with once monthly bisphosphonates only 2 (3.3%) were classified as severe. During the treatment, spontaneous fractures occurred in 13 (7.1%) patients.

Conclusion: Ibadronate treatment once a month for 6 months was shown to be very safe, tolerated well and without more serious side effects.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bone Density Conservation Agents / administration & dosage*
  • Diphosphonates / administration & dosage*
  • Drug Administration Schedule
  • Female
  • Fractures, Compression / prevention & control
  • Humans
  • Ibandronic Acid
  • Middle Aged
  • Osteoporosis, Postmenopausal / drug therapy*
  • Osteoporotic Fractures / prevention & control*

Substances

  • Bone Density Conservation Agents
  • Diphosphonates
  • Ibandronic Acid