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: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: denosumab
Drug: teriparatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Denosumab And Teriparatide Administration Study (DATA)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone Mineral Density by Dual X-ray Absorptiometry (DXA) [ Time Frame: 06/2009-02/2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: denosumab ONLY Drug: denosumab
denosumab: 60 mg SC every 6 months
Experimental: teriparatide (Forteo®) ONLY Drug: teriparatide
teriparatide: 20 mcg SC QD
Other Name: Forteo®
Experimental: denosumab and teriparatide (Forteo®) Drug: denosumab
denosumab: 60 mg SC every 6 months
Drug: teriparatide
teriparatide: 20 mcg SC QD
Other Name: Forteo®

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926380

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Amgen
Investigators
Principal Investigator: Benjamin Z Leder, MD Massachusetts General Hospital
Principal Investigator: Robert M Neer, MD Massachusetts General Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benjamin Leder, MD, Principal Investigator, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00926380     History of Changes
Other Study ID Numbers: 20080723, 2009P000525
Study First Received: June 19, 2009
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
osteoporosis
postmenopausal
denosumab
teriparatide
Forteo®
DXA
Bone Mineral Density
pQCT

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014