Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (DATA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00926380
First received: June 19, 2009
Last updated: August 28, 2014
Last verified: August 2014

June 19, 2009
August 28, 2014
June 2009
February 2015   (final data collection date for primary outcome measure)
Bone Mineral Density by Dual X-ray Absorptiometry (DXA) [ Time Frame: 06/2009-02/2015 ] [ Designated as safety issue: No ]
Bone Mineral Density by Dual X-ray Absorptiometry (DXA) [ Time Frame: 06/2009-08/2012 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926380 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
The Denosumab And Teriparatide Administration Study (DATA)

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
  • Drug: denosumab
    denosumab: 60 mg SC every 6 months
  • Drug: teriparatide
    teriparatide: 20 mcg SC QD
    Other Name: Forteo®
  • Experimental: denosumab ONLY
    Intervention: Drug: denosumab
  • Experimental: teriparatide (Forteo®) ONLY
    Intervention: Drug: teriparatide
  • Experimental: denosumab and teriparatide (Forteo®)
    Interventions:
    • Drug: denosumab
    • Drug: teriparatide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Must satisfy A and B and C and D below:

  • (A) Women aged > 55
  • (B) Postmenopausal
  • (C) Osteoporotic with high risk of fracture

Exclusion Criteria:

  • Confirmed serum alkaline phosphatase above upper normal limit with no explanation
  • Liver disease (AST or ALT > 2 x upper normal limit).
  • Renal disease (serum creatinine > 2.0 mg/dl).
  • Hypercalcemia (Ca >10.5 mg/dL)
  • Elevated blood PTH (intact PTH > 65 pg/ml)
  • Serum 25-OH vitamin D < 20 ng/ml
  • HCT < 32%.
  • History of malignancy (except basal cell carcinoma) or radiation therapy.
  • Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
  • Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
  • Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
  • Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
  • Current use or use in the past 6 months of oral bisphosphonate
  • Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
  • Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
  • Any current or previous use of strontium or any parenteral bisphosphonate.
  • Known sensitivity to mammalian cell-derived drug products.
  • Known sensitivity to teriparatide or any of its excipients.
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00926380
20080723, 2009P000525
Yes
Benjamin Leder, MD, Massachusetts General Hospital
Massachusetts General Hospital
Amgen
Principal Investigator: Benjamin Z Leder, MD Massachusetts General Hospital
Principal Investigator: Robert M Neer, MD Massachusetts General Hospital
Massachusetts General Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP