Adding Phosphorus to Osteoporosis Drug Treatment

NCT00074711 | Completed Phase 2 Results

• 1 other identifier: R01AR048846
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Osteopenia

Keywords

Bone Mineral Density; Calcium

Outcome Measures

Primary Outcomes (2)

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

  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).

  Measured at Baseline

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

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

  12 months

Secondary Outcomes (4)

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

  Measured at baseline and 12 months

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

  Measured at baseline and 12 months

• Change From Baseline in Urinary N-telopeptide at 12 Months

  Measured at baseline and 12 months

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

  Measured at baseline and 12 months

Study Arms (2)

Calcium Phosphate Treatment Group

ACTIVE COMPARATOR

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

Drug: Calcium Phosphate

Calcium Carbonate Treatment Group

ACTIVE COMPARATOR

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

Drug: Calcium carbonate

Interventions

Calcium carbonate DRUG

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

Calcium Carbonate Treatment Group

Calcium Phosphate DRUG

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

Calcium Phosphate Treatment Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (2)

• Heaney 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 RESULT

• Heaney RP, Watson P. Variability in the measured response of bone to teriparatide. Osteoporos Int. 2011 Jun;22(6):1703-8. doi: 10.1007/s00198-010-1376-1. Epub 2010 Sep 9.

  PMID: 20827548 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Calcium Carbonate; calcium phosphate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Results Point of Contact

• Title: Robert P Heaney, MD
• Organization: Creighton University

rpheaney@creighton.edu

402 280 4029

Study Officials

• Robert P. Heaney, MD

  Creighton University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2003
• First Posted: December 22, 2003
• Study Start: August 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-07

Locations

US (1)