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Completed

NCT Number: NCT00532337

Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.

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Key information

Conditions

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

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Andromed Noord Groningen

Damsterdiep 9, Provincie Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR
  • Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score <-1 and >2.5) at the lumbar spine (L1 to L4) or total hip.

Exclusion criteria

  • Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score <-3.5) at the lumbar spine (L1 to L4) or total hip.
  • Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
  • Osteopenia patients (T-score <-1 and >-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR
  • Osteopenia patients (T-score <-1 and >-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
  • Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
  • Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
  • Other exclusion criteria as specified in the study protocol.

Treatment and study plan

ONO-5334

Drug

Placebo - 24/mos.

Primary outcomes

  1. Mean bone mineral density of the lumbar spine (L 1-4 BMD)

    Time frame: 12 months

Secondary outcomes

  1. Bone mineral density at hip, Biochemical markers of bone turnover

    Time frame: during course of treatment of 12 months

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

Important dates

Study start
2007
Primary completion
2010
First posted
Sep 20, 2007
Registry last updated
Jun 13, 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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