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