Trial Outcomes & Findings for Adding Phosphorus to Osteoporosis Drug Treatment (NCT NCT00074711)
NCT ID: NCT00074711
Last Updated: 2016-07-06
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
241 participants
Primary outcome timeframe
Measured at Baseline
Results posted on
2016-07-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
121
|
|
Overall Study
COMPLETED
|
105
|
106
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
8
|
|
Overall Study
Participant stopped study drug
|
4
|
6
|
Baseline Characteristics
Adding Phosphorus to Osteoporosis Drug Treatment
Baseline characteristics by cohort
| Measure |
Calcium Phosphate Treatment Group
n=120 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=121 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Age, Continuous
|
70.09 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
70.07 years
STANDARD_DEVIATION 6.34 • n=7 Participants
|
70.07 years
STANDARD_DEVIATION 6.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
121 participants
n=7 Participants
|
241 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at BaselinePopulation: Postmenopausal women with spinal osteoporosis.
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).
Outcome measures
| Measure |
Calcium Phosphate Treatment Group
n=105 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.
Baseline (Hip)
|
0.76 g/cm2
Standard Deviation 0.11
|
0.78 g/cm2
Standard Deviation 0.10
|
|
Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.
Baseline (Spine)
|
0.88 g/cm2
Standard Deviation 0.12
|
0.86 g/cm2
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants that completed study.
The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).
Outcome measures
| Measure |
Calcium Phosphate Treatment Group
n=105 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).
Hip Bone Mineral Density
|
0.01680 g/cm2
Standard Error 0.00227
|
0.01450 g/cm2
Standard Error 0.00203
|
|
Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).
Spine Bone Mineral Density
|
0.0609 g/cm2
Standard Error 0.00356
|
0.0607 g/cm2
Standard Error 0.00336
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsOutcome measures
| Measure |
Calcium Phosphate Treatment Group
n=105 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
S Phos
|
0.139 mg/dl
Standard Error 0.045
|
0.245 mg/dl
Standard Error 0.042
|
|
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
S Crt
|
-0.001 mg/dl
Standard Error 0.012
|
0.051 mg/dl
Standard Error 0.012
|
|
Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months
S Ca
|
-0.048 mg/dl
Standard Error 0.041
|
0.001 mg/dl
Standard Error 0.047
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsOutcome measures
| Measure |
Calcium Phosphate Treatment Group
n=105 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months
Ca to CRT
|
0.021 g/g
Standard Error 0.010
|
0.011 g/g
Standard Error 0.010
|
|
Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months
Ph to CRT
|
0.073 g/g
Standard Error 0.025
|
-0.053 g/g
Standard Error 0.028
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsOutcome measures
| Measure |
Calcium Phosphate Treatment Group
n=105 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Change From Baseline in Urinary N-telopeptide at 12 Months
|
16.0 nmol bce/mmol
Standard Error 3.42
|
17.1 nmol bce/mmol
Standard Error 2.79
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsOutcome measures
| Measure |
Calcium Phosphate Treatment Group
n=105 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 Participants
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months
|
5.61 micromol/mmol
Standard Error 1.25
|
6.26 micromol/mmol
Standard Error 0.962
|
Adverse Events
Calcium Phosphate Treatment Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Calcium Carbonate Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Calcium Phosphate Treatment Group
n=105 participants at risk
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
|
Calcium Carbonate Treatment Group
n=106 participants at risk
Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
|
|---|---|---|
|
Cardiac disorders
Death
|
0.95%
1/105 • Number of events 1 • 12 months
|
0.00%
0/106 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place