Adding Phosphorus to Osteoporosis Drug Treatment

• Sponsor: Creighton University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00074711
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), Office of Dietary Supplements (ODS) (NIH)
• Enrollment: 241
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Osteopenia	Drug: Calcium carbonate; Drug: Calcium Phosphate	Phase 2

Detailed Description

Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density (BMD) during the course of the study than the group not receiving phosphate.

All participants will receive teriparatide and vitamin D during the course of the 12-month study. Participants will be randomly assigned to one of two groups. One group will receive calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine and hip at baseline and at 3, 6, and 12 months of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Bone Sparing by Calcium Salts With and Without Extra Phosphorus
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Calcium Phosphate; 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.	Drug: Calcium carbonate; Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Outcome Measures

Primary Outcome Measures

1. Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. [Measured at Baseline]

   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). [12 months]

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

Secondary Outcome Measures

1. Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months [Measured at baseline and 12 months]

2. Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months [Measured at baseline and 12 months]

3. Change From Baseline in Urinary N-telopeptide at 12 Months [Measured at baseline and 12 months]

4. Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months [Measured at baseline and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Creighton University Medical Center	Omaha	Nebraska	United States	68131

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Robert P. Heaney, MD, Creighton University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Creighton University
• ClinicalTrials.gov Identifier: NCT00074711
• Other Study ID Numbers: R01AR048846; R01AR048846
• First Posted: Dec 22, 2003
• Last Update Posted: Jul 6, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Creighton University: Bone Mineral Density; Calcium
• Additional relevant MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Calcium, Dietary; Calcium Carbonate; Calcium

Study Results

Participant Flow

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Period Title: Overall Study
STARTED	120	121
COMPLETED	105	106
NOT COMPLETED	15	15

Baseline Characteristics

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group	Total
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.	Total of all reporting groups
Overall Participants	120	121	241
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 4.2%	6 5%	11 4.6%
>=65 years	115 95.8%	115 95%	230 95.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.09 (7.02)	70.07 (6.34)	70.07 (6.38)
Sex: Female, Male (Count of Participants)
Female	120 100%	121 100%	241 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	120 100%	121 100%	241 100%

Outcome Measures

1. Primary Outcome

Title	Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.
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).
Time Frame	Measured at Baseline

Outcome Measure Data

Analysis Population Description

Postmenopausal women with spinal osteoporosis.

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Measure Participants	105	106
Baseline (Hip)	0.76 (0.11)	0.78 (0.10)
Baseline (Spine)	0.88 (0.12)	0.86 (0.12)

2. Primary Outcome

Title	Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).
Description	The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Participants that completed study.

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Measure Participants	105	106
Hip Bone Mineral Density	0.01680 (0.00227)	0.01450 (0.00203)
Spine Bone Mineral Density	0.0609 (0.00356)	0.0607 (0.00336)

3. Secondary Outcome

Title	Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
Time Frame	Measured at baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Measure Participants	105	106
S Phos	0.139 (0.045)	0.245 (0.042)
S Crt	-0.001 (0.012)	0.051 (0.012)
S Ca	-0.048 (0.041)	0.001 (0.047)

4. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Measure Participants	105	106
Ca to CRT	0.021 (0.010)	0.011 (0.010)
Ph to CRT	0.073 (0.025)	-0.053 (0.028)

5. Secondary Outcome

Title	Change From Baseline in Urinary N-telopeptide at 12 Months
Time Frame	Measured at baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Measure Participants	105	106
Mean (Standard Error) [nmol bce/mmol]	16.0 (3.42)	17.1 (2.79)

6. Secondary Outcome

Title	Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months
Time Frame	Measured at baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Calcium Phosphate Treatment Group	Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Measure Participants	105	106
Mean (Standard Error) [micromol/mmol]	5.61 (1.25)	6.26 (0.962)

Adverse Events

Time Frame	12 months
Arm/Group Title	Calcium Phosphate Treatment Group		Calcium Carbonate Treatment Group
Arm/Group Description	Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.		Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
All Cause Mortality
	Calcium Phosphate Treatment Group		Calcium Carbonate Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Calcium Phosphate Treatment Group		Calcium Carbonate Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/105 (1%)		0/106 (0%)
Cardiac disorders
Death	1/105 (1%)	1	0/106 (0%)	0
Other (Not Including Serious) Adverse Events
	Calcium Phosphate Treatment Group		Calcium Carbonate Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/106 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.