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Completed

NCT Number: NCT00377819

Study of Transitioning From Alendronate to Denosumab

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

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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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal females 55 yrs or older
  • Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
  • Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4

Exclusion criteria

  • Vitamin D deficiency
  • Administration of intravenous bisphosphonate, or
  • fluoride (except for dental treatment) or
  • strontium ranelate
  • Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
  • Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening

Treatment and study plan

Alendronate

Drug

70 mg oral QW

Denosumab (AMG 162)

Drug

60 mg SC q 6 mos

Primary outcomes

  1. Percent Change From Baseline in Total Hip Bone Mineral Density

    Time frame: Baseline, 12 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.

Secondary outcomes

  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density

    Time frame: Baseline, 12 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.

  2. Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)

    Time frame: Baseline, 3 months

    Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2006
Registry last updated
Jul 11, 2011

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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