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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

NCTNCT01750086 (opens ClinicalTrials.gov in a new tab)Other id2012P001956
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
27 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2013
Primary completion
Apr 2014
Completion
Aug 2014
First posted
17 Dec 2012 (estimated)
Last update posted
27 Mar 2017
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 4

    Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

    NCT01750086

    Jan 2013 to Aug 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Teriparatide 40-mcg subcutaneous injectionDrug
  • Denosumab InjectionDrug
  • Alendronate Oral TabletDrug

Arms2

  • Active comparator

    Denosumab 60mg subcutaneous injection

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

  • Active comparator

    Alendronate 70mg weekly x 8 weeks

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bone Turnover Marker (Blood Sample)

    Time frame · 8 weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 8 weeks

Bone Turnover Marker (Blood Sample)

GroupValue (percentage of change in CTX)Spread
Denosumab 60mg Subcutaneous Injection-711
Alendronate 70mg Weekly x 8 Weeks4329

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Denosumab 60mg Subcutaneous InjectionEach subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection–1 / 120 / 12
Alendronate 70mg Weekly x 8 WeeksEach subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection–1 / 130 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate.

Tsai et al. 2015The Journal of clinical endocrinology and metabolismcited by 6

PMID 25933031PMC5393530DOI 10.1210/jc.2015-1541PUB-25933031

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2011

12 results

Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis.

Cosman et al. 2011Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 246

PMID 20814967DOI 10.1002/jbmr.238PUB-20814967

Full text at the publisher12 results
Publisher pageSee results (12)

Indexing hint: Randomized controlled trial · 2010

10 results

Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis.

Finkelstein et al. 2010The Journal of clinical endocrinology and metabolismcited by 198

PMID 20164296PMC2853981DOI 10.1210/jc.2009-1703PUB-20164296

Rights unknown10 results
Source linkSee results (10)

Indexing hint: Animal study · 2001

8 results

OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats.

Kostenuik et al. 2001Endocrinologycited by 97

PMID 11564687DOI 10.1210/endo.142.10.8437PUB-11564687

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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