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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 28, 2014
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 October 19, 2014