OsteoporosisPhase 2NCT00074711
Adding Phosphorus to Osteoporosis Drug Treatment
A Phase 2 study testing Calcium carbonate and Calcium Phosphate in people with Osteoporosis and Osteopenia, run by Creighton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Calcium carbonate and Calcium Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Official title: Bone Sparing by Calcium Salts With and Without Extra Phosphorus
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.
Read the 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.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Calcium carbonate, Calcium Phosphate
- Keywords
- Bone Mineral Density, Calcium
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium carbonateDrug
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
Calcium PhosphateDrug
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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).
Measured: 12 months
Secondary outcomes (4)
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
Measured: Measured at baseline and 12 months
Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months
Measured: Measured at baseline and 12 months
Change From Baseline in Urinary N-telopeptide at 12 Months
Measured: Measured at baseline and 12 months
Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months
Measured: Measured at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2003 (estimated)
- Study startAug 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Robert P. Heaney, MD, Principal investigator, Creighton University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074711
- Sponsor's protocol ID
- R01AR048846
- Other IDs
- R01AR048846
- Status last verified
- Jul 2016
- First submitted
- 19 Dec 2003
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20484446Heaney 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.
PubMed 20827548
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Sparing by Calcium Salts With and Without Extra Phosphorus
- ClinicalTrials.gov ID
- NCT00074711
- Acronym / sponsor ID
- R01AR048846
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Bone Mineral Density, Calcium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Dietary Supplements (ODS)
- Study start
- Aug 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Dec 2003 (estimated)
- Results
- Posted 6 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Phosphate Treatment Group | Active comparator | Drug: Calcium PhosphateParticipants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. |
| Calcium Carbonate Treatment Group | Active comparator | Drug: Calcium carbonateParticipants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Paget's disease or history of osteosarcoma
- Systemic corticosteroid therapy
- Hyperparathyroidism
- Recent history of kidney stone
- Anticonvulsant therapy known to alter vitamin D metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium carbonateParticipants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. | Drug | Calcium Carbonate Treatment Group |
| Calcium PhosphateParticipants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. | Drug | Calcium Phosphate Treatment Group |
Primary outcome
Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.
Time frame: 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).
Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).
Time frame: 12 months
The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).
4 secondary outcomes
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
Time frame: Measured at baseline and 12 months
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
Change From Baseline in Urinary N-telopeptide at 12 Months
Time frame: Measured at baseline and 12 months
Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months
Time frame: Measured at baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20484446Heaney 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.
- Derived from this study: PubMed 20827548Heaney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P. Heaney, MD principal investigator
Creighton University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium carbonate and Calcium Phosphate in people with Osteoporosis and Osteopenia, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter. (time frame: Measured at Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.