NCT01753856

Anabolism Versus Antiresorption: A Quadruple Labeling Histomorphometry Study to Compare the Mechanism of Action of Teriparatide and Denosumab in Postmenopausal Women With Osteoporosis

Completed Phase 4 Results posted Last updated 11 September 2015

What this trial tests

Phase 4 trial testing Teriparatide in Osteoporosis in 69 participants. Completed in 1 June 2014.

Timeline

1 January 2013

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	69
Start date	1 January 2013
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	6 locations across United States, Canada

Drugs / interventions tested

• Teriparatide — full drug profile →
• Denosumab (DENOSUMAB) — full drug profile →
• Demeclocycline (DEMECLOCYCLINE) — full drug profile →
• Tetracycline — full drug profile →
• Calcium Supplement
• Vitamin D

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 55 to 89, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies
  Time frame: Baseline, 3 months post first dose of study drug
  MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling, and calculated as the sum of the total extent of double label (DL) plus half the extent of single label (SL) divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the

Sponsor's own description

The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Differential Effects of Teriparatide and Denosumab on Intact PTH and Bone Formation Indices: AVA Osteoporosis Study.
   Dempster DW, Zhou H, Recker RR, Brown JP, et al · · 2016 · cited 46× · PMID 26859106 · DOI 10.1210/jc.2015-4181