Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01750086
First received: November 26, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Teriparatide 40-mcg subcutaneous injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone turnover marker (blood sample) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection
Other Name: Forteo®
Active Comparator: Alendronate 70mg weekly x 8 weeks
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection
Other Name: Forteo®

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Must satisfy A and B and C below:

A. Women aged 45+

B. Postmenopausal

C. Osteoporotic with high risk of fracture

Exclusion Criteria:

  • History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
  • Current alcohol or substance abuse
  • Major psychiatric disorders
  • Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
  • Known congenital or acquired bone disease other than osteoporosis
  • Current use or past use in the past 12 months of oral bisphosphonates
  • Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
  • Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
  • Any current or previous use of strontium or intravenous bisphosphonates
  • Sensitivity to cell-derived drug products or teriparatide
  • Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
  • Inability to sit upright for 30 minutes
  • Esophageal abnormalities
  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: NCT01750086

Contacts
Contact: Benjamin Z Leder, MD 617-724-2039 bzleder@partners.org
Contact: Joy N Tsai, MD 6177264650 jntsai@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Joy Tsai, MD    617-726-4650      
Principal Investigator: Benjamin Z Leder, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01750086     History of Changes
Other Study ID Numbers: 2012P001956
Study First Received: November 26, 2012
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
osteoporosis
postmenopausal
denosumab
teriparatide
alendronate
Forteo®
Prolia®

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

ClinicalTrials.gov processed this record on November 24, 2014