Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

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ClinicalTrials.gov Identifier: NCT01750086

Recruitment Status : Completed

First Posted : December 17, 2012

Results First Posted : January 26, 2017

Last Update Posted : March 27, 2017

Sponsor:

Information provided by (Responsible Party):

Benjamin Leder, MD, Massachusetts General Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Postmenopausal Osteoporosis	Drug: Teriparatide 40-mcg subcutaneous injection Drug: Denosumab Injection Drug: Alendronate Oral Tablet	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
Study Start Date :	January 2013
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate Denosumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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® Drug: Denosumab Injection One-time Denosumab injection
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® Drug: Alendronate Oral Tablet weekly alendronate for 8 weeks

Outcome Measures

Primary Outcome Measures :

Bone Turnover Marker (Blood Sample) [ Time Frame: 8 weeks ]
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750086

Locations


United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

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
First Posted:	December 17, 2012 Key Record Dates
Results First Posted:	January 26, 2017
Last Update Posted:	March 27, 2017
Last Verified:	February 2017

Keywords provided by Benjamin Leder, MD, 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 Metabolic Diseases	Denosumab Alendronate Teriparatide Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs

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