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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Short name DATA

NCTNCT00926380 (opens ClinicalTrials.gov in a new tab)Other id20080723Other id2009P000525

Overview

Status
Completed
Phase
Phase 2
Enrollment
94 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2009
Primary completion
Dec 2016
Completion
Dec 2016
First posted
23 Jun 2009 (estimated)
Last update posted
29 Jun 2018
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201220142016
  1. Ph 2

    DATA

    NCT00926380

    Jun 2009 to Dec 2016

Registry summary

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

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

Interventions

  • denosumabDrug
  • teriparatideDrug

Arms3

  • Experimental

    denosumab ONLY

  • Experimental

    teriparatide (Forteo®) ONLY

  • Experimental

    denosumab and teriparatide (Forteo®)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Spine Bone Density From Baseline to 2 Years

    Time frame · Baseline and 2 years

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· Baseline and 2 years

Change in Spine Bone Density From Baseline to 2 Years

GroupValue (percent change)Spread
Denosumab ONLY8.33.4
Teriparatide (Forteo®) ONLY9.55.9
Denosumab and Teriparatide (Forteo®)12.95.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Denosumab ONLYdenosumab: denosumab: 60 mg SC every 6 months–1 / 334 / 33
Teriparatide (Forteo®) ONLYteriparatide: teriparatide: 20 mcg SC QD–2 / 315 / 31
Denosumab and Teriparatide (Forteo®)denosumab: denosumab: 60 mg SC every 6 months teriparatide: teriparatide: 20 mcg SC QD–1 / 304 / 30

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

Studies6

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2016

16 results

Effects of Two Years of Teriparatide, Denosumab, or Both on Bone Microarchitecture and Strength (DATA-HRpQCT study).

Tsai et al. 2016The Journal of clinical endocrinology and metabolismcited by 84

PMID 26964731PMC4870854DOI 10.1210/jc.2016-1160PUB-26964731

Rights unknown16 results

Indexing hint: Randomized controlled trial · 2015

18 results

Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial.

Leder et al. 2015Lancet (London, England)cited by 426

PMID 26144908PMC4620731DOI 10.1016/s0140-6736(15)61120-5PUB-26144908

Rights unknown18 results

Indexing hint: Randomized controlled trial · 2013

9 results

Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial.

Tsai et al. 2013Lancet (London, England)cited by 335

PMID 23683600PMC4083737DOI 10.1016/s0140-6736(13)60856-9PUB-23683600

Rights unknown9 results

Indexing hint: Randomized controlled trial · 2001

12 results

Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.

Neer et al. 2001The New England journal of medicinecited by 3,051

PMID 11346808DOI 10.1056/nejm200105103441904PUB-11346808

Rights unknown12 results

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

More studies

1 study on this page

Indexing hint: Clinical trial · 2014

Teriparatide (PTH 1-34) treatment increases peripheral hematopoietic stem cells in postmenopausal women.

Yu et al. 2014Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 23

PMID 24420643PMC4564394DOI 10.1002/jbmr.2171PUB-24420643

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Must satisfy A and B and C and D below: * (A) Women aged \> 55 * (B) Postmenopausal * (C) Osteoporotic with high risk of fracture Exclusion Criteria: * Confirmed serum alkaline phosphatase above upper normal limit with no explanation * Liver disease (AST or ALT \> 2 x upper normal limit). * Renal disease (serum creatinine \> 2.0 mg/dl). * Hypercalcemia (Ca \>10.5 mg/dL) * Elevated blood PTH (intact PTH \> 65 pg/ml) * Serum 25-OH vitamin D \< 20 ng/ml * HCT \< 32%. * History of malignancy (except basal cell carcinoma) or radiation therapy. * Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures. * Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. * Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. * Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease) * Current use or use in the past 6 months of oral bisphosphonate * Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin. * Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months. * Any current or previous use of strontium or any parenteral bisphosphonate. * Known sensitivity to mammalian cell-derived drug products. * Known sensitivity to teriparatide or any of its excipients.

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