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NCT Number: NCT02157948

A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

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Key information

Conditions

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

Age range

55 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has provided informed consent prior to any study-specific activities/procedures
  • Ambulatory postmenopausal women.
  • Age 55 years or older
  • Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar spine, total hip, or femoral neck.

Exclusion criteria

  • Administration of osteoporosis treatments or bone active treatments within specific timeframes
  • Vitamin D deficiency
  • Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism; hypo/hyperthyroidism, unless stable and well-controlled)
  • Contraindications to denosumab therapy (e.g., hypocalcemia)

Treatment and study plan

Denosumab (CP2)

Drug

Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.

Other names: XGEVA®

Denosumab (CP4)

Drug

Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

Primary outcomes

  1. Percent Change From Baseline in Lumbar Spine BMD

    Time frame: Baseline and Month 12

    Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Secondary outcomes

  1. Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)

    Time frame: Baseline, month 1, month 6 and month 12

  2. Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

    Time frame: Baseline, month 1, month 6 and month 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2014
Registry last updated
Aug 16, 2017

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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