Completed

Bone Sparing by Calcium Salts With and Without Extra Phosphorus

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What is being tested

Calcium carbonate

+ Calcium Phosphate
Drug
Who is being recruted

Bone Diseases
+2

+ Bone Diseases, Metabolic
+ Metabolic Diseases
From 60 to 85 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2004
See protocol details

Summary

Principal SponsorCreighton University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleBone Sparing by Calcium Salts With and Without Extra Phosphorus 
NCT00074711
Principal SponsorCreighton University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
241 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 60 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bone Diseases
Bone Diseases, Metabolic
Metabolic Diseases
Musculoskeletal Diseases
Osteoporosis
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Group II
Active Comparator
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 phosphate.
Study Objectives
Primary Objectives

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).

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Creighton University Medical CenterOmaha, United StatesSee the location
CompletedOne Study Center
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