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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: Teriparatide 40-mcg subcutaneous injection (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Overall contact:
Benjamin Z Leder, MD, Phone: 617-724-2039, Email: bzleder@partners.org

Summary

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

Clinical Details

Official title: Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

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

Primary outcome: Bone turnover marker (blood sample)

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Benjamin Z Leder, MD, Phone: 617-724-2039, Email: bzleder@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Joy Tsai, MD, Phone: 617-726-4650
Benjamin Z Leder, MD, Principal Investigator
Additional Information

Related publications:

Cosman F, Eriksen EF, Recknor C, Miller PD, GuaƱabens 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.

Starting date: January 2013
Last updated: August 28, 2014

Page last updated: August 23, 2015

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