Bone Sparing by Calcium Salts With and Without Extra Phosphorus
Calcium carbonate
+ Calcium Phosphate
Bone Diseases+2
+ Bone Diseases, Metabolic
+ Metabolic Diseases
Treatment Study
Summary
Study start date: August 1, 2004
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.241 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 60 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
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