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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Adding Phosphorus to Osteoporosis Drug Treatment

NCTNCT00074711 (opens ClinicalTrials.gov in a new tab)Other idR01AR048846Other idR01AR048846
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Teriparatide (PTH 1-34), does not give it. It appears in an outcome measure.

Overview

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

United States

Start
Aug 2004
Primary completion
Jun 2008
Completion
Jun 2008
First posted
22 Dec 2003 (estimated)
Last update posted
6 Jul 2016 (estimated)
Conditions
Osteoporosis · Osteopenia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006200720082009
  1. Ph 2

    Adding Phosphorus to Osteoporosis Drug Treatment

    NCT00074711

    Aug 2004 to Jun 2008

Registry summary

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

Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.

Interventions

  • Calcium carbonateDrug
  • Calcium PhosphateDrug

Arms2

  • Active comparator

    Calcium Phosphate Treatment Group

    Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.

  • Active comparator

    Calcium Carbonate Treatment Group

    Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.

    Time frame · Measured at Baseline

    Registry description

    Bone mineral density (BMD, measured by dual X-ray absorptiometry - DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).

  2. Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).

    Time frame · 12 months

    Registry description

    The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).

Secondary outcomes(4)

  1. Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months

    Time frame · Measured at baseline and 12 months

  2. Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months

    Time frame · Measured at baseline and 12 months

  3. Change From Baseline in Urinary N-telopeptide at 12 Months

    Time frame · Measured at baseline and 12 months

  4. Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months

    Time frame · Measured at baseline and 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· Measured at Baseline

Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.

GroupValue (g/cm2)Spread
Calcium Phosphate Treatment Group0.760.11
Calcium Carbonate Treatment Group0.780.10
Primary outcomeMean· 12 months

Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).

GroupValue (g/cm2)Spread
Calcium Phosphate Treatment Group0.016800.00227
Calcium Carbonate Treatment Group0.014500.00203
Secondary and other outcome results(4)
Secondary outcomeMean· Measured at baseline and 12 months

Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months

GroupValue (mg/dl)Spread
Calcium Phosphate Treatment Group0.1390.045
Calcium Carbonate Treatment Group0.2450.042
Secondary outcomeMean· Measured at baseline and 12 months

Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months

GroupValue (g/g)Spread
Calcium Phosphate Treatment Group0.0210.010
Calcium Carbonate Treatment Group0.0110.010
Secondary outcomeMean· Measured at baseline and 12 months

Change From Baseline in Urinary N-telopeptide at 12 Months

GroupValue (nmol bce/mmol)Spread
Calcium Phosphate Treatment Group16.03.42
Calcium Carbonate Treatment Group17.12.79
Secondary outcomeMean· Measured at baseline and 12 months

Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months

GroupValue (micromol/mmol)Spread
Calcium Phosphate Treatment Group5.611.25
Calcium Carbonate Treatment Group6.260.962

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Calcium Phosphate Treatment GroupParticipants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.–1 / 1050 / 105
Calcium Carbonate Treatment GroupParticipants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.–0 / 1060 / 106

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

3 results

Variability in the measured response of bone to teriparatide.

Heaney et al. 2011Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 17

PMID 20827548DOI 10.1007/s00198-010-1376-1PUB-20827548

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

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHeaney RP, Recker RR, Watson P, Lappe JM. Phosphate and carbonate salts of calcium support robust bone building in osteoporosis. Am J Clin Nutr. 2010 Jul;92(1):101-5. doi: 10.3945/ajcn.2009.29085. Epub 2010 May 19. PMID 20484446

Eligibility

Who could join, as posted.

Sex
Female
Age
from 60 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Bone mineral density (BMD) T-score less than -1.0 * One or more vertebral fractures * Serum creatinine less than 1.3 mg/dL * Serum phosphorus less than 3.6 mg/dL * Daily phosphorus intake below NHANES-III median * Body mass index (BMI) less than 30 kg/m2 Exclusion Criteria: * Paget's disease or history of osteosarcoma * Systemic corticosteroid therapy * Hyperparathyroidism * Recent history of kidney stone * Anticonvulsant therapy known to alter vitamin D metabolism * Radiation therapy to bone

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