Trial · Interventional

CompletedPhase 2Results postedRegistry data

Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

NCTNCT00086619Other idNIAMS-123Other id1P50AR044855

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Teriparatide (PTH 1-34), does not test it. It appears in the conditions.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 80 participants (actual)
Sponsor: Massachusetts General Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: May 2004
Primary completion: Dec 2009
Completion: Dec 2009
First posted: 8 Jul 2004 (estimated)
Last update posted: 30 Oct 2013 (estimated)
Conditions: Postmenopausal Osteoporosis · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

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

2004200520062007200820092010

Ph 2
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
NCT00086619
May 2004 to Dec 2009

Registry summary

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

Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.

Interventions

synthetic hPTH 1-34Drug

Arms2

Experimental
constant dose
Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a constant dose of 30 mcg/day.
Experimental
ascending dose
Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a dose that ascends at 6 month intervals (20-30-40 mcg/day).

Primary outcomes1

Outcomes the sponsor listed as primary.

Changes in Indices of Bone Turnover
Time frame · Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.
Registry description
Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months\*ng/ml) for the marker.

Secondary outcomes(1)

Change in Bone Mineral Density (BMD)
Time frame · baseline and 18 months (12 months in 4 subjects)
Registry description
Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100\*\[(final - month 0)/month 0\] in subjects who took study therapy for at least 12 months.

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· Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.

Changes in Indices of Bone Turnover

Group	Value (months*(ng/ml - baseline ng/ml))	Spread
Constant Dose PTH	4418	2732
Ascending Dose PTH	3696	1735

Secondary and other outcome results(1)

Secondary outcomeMean· baseline and 18 months (12 months in 4 subjects)

Change in Bone Mineral Density (BMD)

Group	Value (percent change)	Spread
Constant Dose PTH	-4.6	2.8
Ascending Dose PTH	-3.1	3.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Constant Dose PTHParticipants received constant dose synthetic hPTH 1-34 (30 mcg/day).	–	0 / 40	5 / 40
Ascending Dose PTHParticipants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).	–	2 / 40	8 / 40

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

5 results

Time-dependent changes in skeletal response to teriparatide: escalating vs. constant dose teriparatide (PTH 1-34) in osteoporotic women.

Yu et al. 2011Bonecited by 17

PMID 21111078PMC3073572DOI 10.1016/j.bone.2010.11.012PUB-21111078

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: Female
Age: from 46 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Three or more years after menopause * Bone mineral density T-score \< or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae Exclusion Criteria: * Cannot walk without assistance * Significant heart, kidney, liver, or malignant disease * Current alcohol abuse * Major psychiatric disorders * Other current or past disorders known to affect bone * Use of medications known to affect bone for \> 7 days in the past 12 months * Use of bisphosphonates or fluoride * Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count * Elevated calcium levels in 24-hour urine collection

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