Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Postmenopausal Osteoporosis Clinical Trial

Official title:

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750086
• Other study ID #: 2012P001956
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2012
• Last updated: November 30, 2016
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Resorption
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Teriparatide 40-mcg subcutaneous injection

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover marker (blood sample)		Up to 2 years	No