Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

• ClinicalTrials.gov Identifier: NCT01750086
• Recruitment Status: Completed
• First Posted: December 17, 2012
• Results First Posted: December 1, 2016
• Last Update Posted: March 27, 2017
• Sponsor: Massachusetts General Hospital
• 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

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 :

1. 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

• 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

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
• Other Study ID Numbers: 2012P001956
• First Posted: December 17, 2012
• Results First Posted: December 1, 2016
• 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; Bone Density Conservation Agents; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents