Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2014 by Massachusetts General Hospital.
Recruitment status was Recruiting

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

History of Changes

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:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Denosumab

U.S. FDA Resources

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 (Adult, Senior)
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:

Cosman F, Eriksen EF, Recknor C, Miller PD, Guañabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238.

Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. Epub 2003 Sep 20.

Cosman F, Nieves J, Zion M, Woelfert L, Luckey M, Lindsay R. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med. 2005 Aug 11;353(6):566-75.

Kostenuik PJ, Capparelli C, Morony S, Adamu S, Shimamoto G, Shen V, Lacey DL, Dunstan CR. OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats. Endocrinology. 2001 Oct;142(10):4295-304.

Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2010 Apr;95(4):1838-45. doi: 10.1210/jc.2009-1703. Epub 2010 Feb 17.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tsai JN, Zhu Y, Foley K, Lee H, Burnett-Bowie SA, Neer RM, Leder BZ. Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate. J Clin Endocrinol Metab. 2015 Jul;100(7):2718-23. doi: 10.1210/jc.2015-1541. Epub 2015 May 1.


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:


Osteoporosis Osteoporosis, Postmenopausal Bone Resorption Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases	Denosumab Alendronate Teriparatide Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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