Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2004-000138-35-GB
EUCTR2004-000138-35-GB
Active, not recruiting
Phase 1

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis. FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months)

Amgen Inc0 sites7,869 target enrollmentFebruary 10, 2005
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsTreatment of postmenopausal osteoporosisMedDRA version: 8.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Treatment of postmenopausal osteoporosis
Sponsor
Amgen Inc
Enrollment
7869
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 10, 2005
End Date
June 17, 2008
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Amgen Inc

Eligibility Criteria

Inclusion Criteria

  • •\- Postmenopausal, ambulatory women, between 60 and 90 years old
  • •\- BMD T\-score \< –2\.5 at one or more of the following regions: the lumbar spine or total hip
  • •\- Ethical \- Before any study\-specific procedure, the appropriate written informed consent must be obtained
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- BMD T\-score \< \-4\.0 at one or more of the following regions: Lumbar spine or total hip
  • •\- Oral bisphosphonate treatment for osteoporosis:
  • •Ineligible if used for 3 or more years cumulatively;
  • •If used for \>3 months, but \= 3 years, at least a one year period since last dose is necessary for eligibility;
  • •If used \= 3 months at any time in the past, subject is eligible.
  • •\- Administration of intravenous bisphosphonate, fluoride or strontium for osteoporosis within the last 5 years
  • •\- Administration of any of the following treatments within the last 6 weeks:
  • •a)PTH or PTH derivatives, eg, teriparatide
  • •b)Anabolic steroids or testosterone
  • •c)Glucocorticosteroids (\> 5 mg prednisone equivalent per day for more than 10 days)

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
The prospective study of denosumab for the treatment of osteoporosis in hemodialysis patientsOsteoporosis
JPRN-UMIN000022179Yujinkai Medical Corporation Yujin-yamazaki Hospital38
Recruiting
Phase 2
A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasisnon-small cell lung cancer
JPRN-UMIN000008314Dokkyo Medical University Department of Pulmonary Medicine and Clinivcal Immunology40
Completed
Not Applicable
Efficacy and safety of denosumab for the treatment of osteoporosis in patients with renal failure
JPRN-UMIN000011992ephrology Center, Toranomon Hospital Nephrology Center, Toranomon Hospital Kajigaya40
Completed
Phase 3
A randomised, double-blind, placebo controlled trial to examine the effects of total oestradiol depletion on bone microstructure and the efficacy of denosumab in preventing microstructural bone decay in premenopausal women with early breast cancerpremenopausal osteoporosisbreast cancerMetabolic and Endocrine - Other endocrine disordersCancer - BreastMusculoskeletal - Osteoporosis
ACTRN12616001051437Professor Mathis Grossmann74
Completed
Phase 2
The efficacy of the use of denosumab in the prevention of aromatase inhibitor-induced bone loss in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant settingBreast Cancer
JPRN-UMIN000013863Department of Endocrine and breast cancer, Kyoto Prefectural University of medicine100