Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

NCT01750086 | Completed Phase 4 Results DMC

• 1 other identifier: 2012P001956
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postmenopausal Osteoporosis

Keywords

osteoporosis; postmenopausal; denosumab; teriparatide; alendronate; Forteo®; Prolia®

Outcome Measures

Primary Outcomes (1)

• Bone Turnover Marker (Blood Sample)

  The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.

  8 weeks

Study Arms (2)

Denosumab 60mg subcutaneous injection

ACTIVE COMPARATOR

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Drug: Teriparatide 40-mcg subcutaneous injection; Drug: Denosumab Injection

Alendronate 70mg weekly x 8 weeks

ACTIVE COMPARATOR

Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.

Drug: Teriparatide 40-mcg subcutaneous injection; Drug: Alendronate Oral Tablet

Interventions

Teriparatide 40-mcg subcutaneous injection DRUG

Also known as: Forteo®

Alendronate 70mg weekly x 8 weeks; Denosumab 60mg subcutaneous injection

Denosumab Injection DRUG

One-time Denosumab injection

Denosumab 60mg subcutaneous injection

Alendronate Oral Tablet DRUG

weekly alendronate for 8 weeks

Alendronate 70mg weekly x 8 weeks

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must satisfy A and B and C below:
• A. Women aged 45+
• B. Postmenopausal
• C. Osteoporotic with high risk of fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens 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.

  PMID: 20814967 BACKGROUND

• 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. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20.

  PMID: 14500805 BACKGROUND

• 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. doi: 10.1056/NEJMoa050157.

  PMID: 16093465 BACKGROUND

• 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. doi: 10.1210/endo.142.10.8437.

  PMID: 11564687 BACKGROUND

• 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.

  PMID: 20164296 BACKGROUND

• 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.

  PMID: 25933031 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Teriparatide; Injections, Subcutaneous; Denosumab; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr. Joy Tsai
• Organization: Massachusetts General Hospital

jntsai@mgh.harvard.edu

617-726-6723

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 17, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 27, 2017
• Results First Posted: December 1, 2016

Record last verified: 2017-02

Locations

US (1)