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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Comparison Study of PTHrP and PTH to Treat Osteoporosis

NCTNCT00853723 (opens ClinicalTrials.gov in a new tab)Other idPRO08100148Other idR01DK051081
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
105 participants (actual)
Sponsor
University of Pittsburgh · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
May 2009
Primary completion
Feb 2012
Completion
Jun 2012
First posted
2 Mar 2009 (estimated)
Last update posted
24 Mar 2016 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 2

    Comparison Study of PTHrP and PTH to Treat Osteoporosis

    NCT00853723

    May 2009 to Jun 2012

Registry summary

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

This is a three month comparison trial of standard dose parathyroid hormone (PTH) (1-34) and two different doses of Parathyroid Hormone-related Protein (PTHrP) (1-36). The investigators want to to demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal women with osteoporosis stimulates bone formation to the same or greater degree than PTH (1-34) but with less bone resorption.

Interventions

  • Parathyroid hormone related protein (1-36)Drug
  • Parathyroid hormone related protein(1-36)Drug
  • Parathyroid hormone (1-34)Drug

Arms3

  • Experimental

    PTHrP 400 mcg/day

    Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.

  • Experimental

    PTHrP 600 mcg/day

    Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.

  • Active comparator

    PTH 20 mcg/day

    Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Procallagen-1 Amino-terminal Peptide (P1NP)

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

  2. Carboxy-terminal Telopeptides of Collagen-1 (CTX)

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

Secondary outcomes(11)

  1. Changes in Bone Mineral Density of the Lumbar Spine.

    Time frame · 90 days

  2. Changes in Bone Mineral Density of the Total Hip.

    Time frame · 90 days

  3. Changes in Bone Mineral Density of the Femoral Neck.

    Time frame · 90 days

  4. Changes in Bone Mineral Density of the Forearm.

    Time frame · 90 days

  5. Changes in Bone Mineral Density of the Distal 1/3 Radius.

    Time frame · 90 days

  6. Total Serum Calcium (mg/dl)

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

  7. Serum Phosphorous

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

  8. 24 Hour Urine Calcium

    Time frame · 90 days

  9. 1,25 Vitamin D

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

  10. Fractional Excretion of Calcium

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

    Registry description

    (Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)

  11. Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)

    Time frame · Baseline, Day 15, Day 30, Day 60, Day 90

    Registry description

    Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP \< or = 0.86 then TMP/GFR = TRP x P phos if TRP \> 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos U= urine, P = plasma

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, Day 15, Day 30, Day 60, Day 90

Procallagen-1 Amino-terminal Peptide (P1NP)

GroupValue (percentage change from baseline)Spread
PTHrP 400 mcg/Day32.545.09
PTHrP 600 mcg/Day23.517.04
PTH 20 mcg/Day60.677.35
Primary outcomeMean· Baseline, Day 15, Day 30, Day 60, Day 90

Carboxy-terminal Telopeptides of Collagen-1 (CTX)

GroupValue (percentage change from baseline)Spread
PTHrP 400 mcg/Day-12.407.19
PTHrP 600 mcg/Day10.2510.66
PTH 20 mcg/Day4.878.09
Secondary and other outcome results(6)
Secondary outcomeMean· 90 days

Changes in Bone Mineral Density of the Lumbar Spine.

GroupValue (Percent change from baseline)Spread
PTHrP 400 mcg/Day1.890.49
PTHrP 600 mcg/Day1.520.61
PTH 20 mcg/Day2.170.60
Secondary outcomeMean· 90 days

Changes in Bone Mineral Density of the Total Hip.

GroupValue (Percent change from baseline)Spread
PTHrP 400 mcg/Day0.680.29
PTHrP 600 mcg/Day0.720.30
PTH 20 mcg/Day0.540.45
Secondary outcomeMean· 90 days

Changes in Bone Mineral Density of the Femoral Neck.

GroupValue (Percent change from baseline)Spread
PTHrP 400 mcg/Day0.910.41
PTHrP 600 mcg/Day0.540.48
PTH 20 mcg/Day0.610.49
Secondary outcomeMean· 90 days

Changes in Bone Mineral Density of the Forearm.

GroupValue (Percent change from baseline)Spread
PTHrP 400 mcg/Day-0.480.61
PTHrP 600 mcg/Day-0.990.78
PTH 20 mcg/Day-0.970.49
Secondary outcomeMean· 90 days

Changes in Bone Mineral Density of the Distal 1/3 Radius.

GroupValue (Percent change from baseline)Spread
PTHrP 400 mcg/Day-0.350.54
PTHrP 600 mcg/Day-0.340.96
PTH 20 mcg/Day-0.820.64
Secondary outcomeMean· Baseline, Day 15, Day 30, Day 60, Day 90

Total Serum Calcium (mg/dl)

GroupValue (mg/dl)Spread
PTHrP 400 mcg/Day9.480.06
PTHrP 600 mcg/Day9.510.06
PTH 20 mcg/Day9.490.06

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PTHrP 400 mcg/DayPost-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.–0 / 3533 / 35
PTHrP 600 mcg/DayPost-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.–0 / 3531 / 35
PTH 20 mcg/DayPost-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.–0 / 3527 / 35

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

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2008

6 results

Head-to-head comparison of risedronate vs. teriparatide on bone turnover markers in women with postmenopausal osteoporosis: a randomised trial.

Anastasilakis et al. 2008International journal of clinical practicecited by 25

PMID 18422590DOI 10.1111/j.1742-1241.2008.01768.xPUB-18422590

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2007

2 results

Occurrence of hypercalciuria in patients with osteoporosis treated with teriparatide.

Miller et al. 2007The Journal of clinical endocrinology and metabolismcited by 37

PMID 17609307DOI 10.1210/jc.2006-2439PUB-17609307

Full text at the publisher2 results
Publisher pageSee results (2)

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
Source linkSee results (12)

Indexing hint: Observational study · 2000

3 results

Six-month daily administration of parathyroid hormone and parathyroid hormone-related protein peptides to adult ovariectomized rats markedly enhances bone mass and biomechanical properties: a comparison of human parathyroid hormone 1-34, parathyroid hormone-related protein 1-36, and SDZ-parathyroid hormone 893.

Stewart et al. 2000Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 96

PMID 10934650DOI 10.1359/jbmr.2000.15.8.1517PUB-10934650

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2005

Corrected

Opposite bone remodeling effects of teriparatide and alendronate in increasing bone mass.

McClung et al. 2005Archives of internal medicinecited by 316

PMID 16087825DOI 10.1001/archinte.165.15.1762PUB-16087825

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 45 - 75 year old Caucasian, Hispanic or Asian women * one year post-menopausal if older than 50 years * three years post-menopausal if between the ages of 45 - 50 years * body mass index less than or equal to 30 * T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of lumbar spine or hip * have at lease two spinal vertebrae evaluable by DXA analysis Exclusion Criteria: * bisphosphonate therapy within the last two years * estrogen replacement hormones or SERMS within last one year * no more than one week of PTHrP, PTH, or an analog of PTH within the last year * an atraumatic bone fracture within the last 6 months * significant or active diseases of any organ system * history of malignancy * anemia with a hematocrit less than 34% * significant drug or alcohol abuse * having received any investigational drug within the last 90 days * taking any medication that may interfere with skeletal metabolism, such as phenobarbital, dilantin, glucocorticoids, and hydrochlorathiazide * abnormal screening labs including serum Ca greater than 10.5 g/dl, 25 hydroxy vitamin D less than 20 ng/ml or PTH greater than 65 pg/ml * African-Americans for this particular study - although future studies are planned

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