Trial · Interventional

Status unknownPhase 2Registry data

Cyclic Versus Daily Teriparatide on Bone Mass

NCTNCT00668941Other idR01 AR056651-01A2, 5RO1 ARO5Other idR01AR056651-01A2

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 2
Enrollment: 140 participants (estimated)
Sponsor: Helen Hayes Hospital · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: Sept 2005
Primary completion: Feb 2016
Completion: Nov 2017 (estimated)
First posted: 29 Apr 2008 (estimated)
Last update posted: 10 Aug 2017
Conditions: Osteoporosis

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200520102015

Ph 2
Cyclic Versus Daily Teriparatide on Bone Mass
NCT00668941
Sept 2005 to est. Nov 2017

Registry summary

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

Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.

Interventions

TeriparatideDrug
AlendronateDrug
CalciumDietary supplement
Vitamin D3Dietary supplement

Arms6

Experimental
1
Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a continuous regimen of daily teriparatide (20 mcg subcutaneously) for 48 months, in addition to alendronate. Biopsies will be performed at Week 7 or Month 7.5. The participants will then have the option to be followed while taking alendronate alone for 24-48 months.
Experimental
2
Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will receive a cyclical regimen of teriparatide, in addition to alendronate. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an aption to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5.
Active comparator
3
Participants in this group will have been treated with alendronate for at least 1 year prior to study entry. Upon study entry, they will continue taking alendronate alone. Biopsies will be performed at Week 7 and then participants in this group will be offered teriparatide as part of Group 2 or 3.
Experimental
4
Participants in this group will receive a continuous regimen of teriparatide (20 mcg delivered subcutaneously) daily for 48 months. Biopsies will be performed at Week 7 or Month 7.5. At 24 months the participants will then have the option of taking alendronate and remaining in the study for another 24 months.
Experimental
5
Participants in this group will receive a cyclical regimen of teriparatide. Teriparatide will be administered subcutaneously in 20-mcg doses daily for 3 months. They will receive no teriparatide for the following 3 months, and then teriparatide treatment will continue for the 3 months after that. This schedule will continue for 24 months with an option to all participants to continue cyclic teriparatide for another 24 months. Biopsies will be performed at Week 7 or Month 7.5.
Active comparator
6
Participants in this group will take only calcium and vitamin D supplements. Biopsies will be performed at Week 7. Participants will then be offered the standard care for osteoporosis or they may enter the study in Group 4 or 5.

Primary outcomes1

Outcomes the sponsor listed as primary.

Bone density
Time frame · 24 and 48 months

Secondary outcomes(2)

Histomorphometry of iliac crest bone biopsies
Time frame · Measured at Week 7 and Month 7
HRpQCT (tibia, radius) and QCT (spine and hip)and FEA of these QCT scans
Time frame · 48 months

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

6 results

Effects of four-year cyclic versus two-year daily teriparatide treatment on volumetric bone density and bone strength in postmenopausal women with osteoporosis.

Ganapathy et al. 2023Bonecited by 10

PMID 36410666PMC9822869DOI 10.1016/j.bone.2022.116618PUB-36410666

Rights unknown6 results

Source link See results (6)

Indexing hint: Randomized controlled trial · 2019

18 results

Administration of teriparatide for four years cyclically compared to two years daily in treatment Naïve and alendronate treated women.

Cosman et al. 2019Bonecited by 16

PMID 30355512DOI 10.1016/j.bone.2018.10.020PUB-30355512

Full text at the publisher18 results

Publisher page See results (18)

Eligibility

Who could join, as posted.

Sex: Female
Age: from 45 Years up to 85 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosis of osteoporosis or T score below -2 plus one or more osteoporosis related fractures * Two measurable vertebrae between L1 and L4 * Willing to undergo a single iliac crest biopsy after administration of 4 tetracycline labels Exclusion Criteria: * Secondary causes of osteoporosis or presence of a skeletal disorder other than osteoporosis * Uses drugs likely to affect skeletal or calcium homeostasis * Multiple vertebral fractures or severe degenerative changes with fewer than two evaluable vertebrae * Unwilling to undergo a single iliac crest biopsy * History of allergy to tetracyclines, exposure to tetracyclines within the last year, or any remote long term use of tetracyclines * Current use of anti-resorptive medicines (other than alendronate for half the female participants) * Use of hormone therapy, estrogen therapy, raloxifene, or calcitonin within 6 months before study entry * Use of any bisphosphonate for more than 3 months within 2 years before study entry (only applies to participants in Groups 4, 5, and 6) * History of a kidney stone within 5 years before study entry or any history of multiple kidney stones * Hypercalcemia, hypercalciuria, or elevated parathyroid hormone (reduced 25-hydroxyvitamin D will be corrected prior to admission) * Esophageal ulceration or stricture or known hypersensitivity to bisphosphonates * History of external radiation therapy * Unlikely or unable to complete the study, as determined by the investigators * Illicit drug use or excessive alcohol consumption

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