Osteoporosis
Conditions
Brief summary
The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.
Interventions
DRUGteriparatide
Subcutaneous, 20 microgram (mcg)/day, 18 months
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory with osteoporosis * Hip or spine bone mineral density (BMD) measurement more than 2.5 standard deviations below the average bone mass of young healthy women or more than 2.0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture.
Exclusion criteria
* Diseases of bone other than osteoporosis * Treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year * Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment * Increased risk for the development of osteosarcoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months | baseline, 18 months | Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Baseline, 3 months, 18 months, 24 months | Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities. |
| Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Baseline, 3 months, 18 months, 24 months | Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma. |
| Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | Baseline, 3 months, 18 months, 24 months | Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting \<1% of skeleton; 2=focal areas affecting \>=5% of skeleton; 3=focal areas affecting \>=20% of skeleton; 4=focal areas affecting \>=50% of skeleton. |
| Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | baseline, 3 months, 18 months, 24 months | Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teriparatide Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Teriparatide |
|---|---|
| Age Continuous | 67.17 years STANDARD_DEVIATION 7.64 |
| Body Mass Index (BMI) | 24.56 kg/m2 STANDARD_DEVIATION 5.16 |
| Height | 161.25 centimeter STANDARD_DEVIATION 6.88 |
| Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate definite increase | 0 participants |
| Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate no increase | 10 participants |
| Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate not assessed | 2 participants |
| Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate possible increase | 0 participants |
| Qualitative Visual Score of Focal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) | 0.7 units on scale STANDARD_DEVIATION 0.48 |
| Race/Ethnicity, Customized Caucasian | 12 participants |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) lower extremities | 9.12 milliliter/minute |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) mandible | 0.17 milliliter/minute |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) pelvis | 5.92 milliliter/minute |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) skull | 3.07 milliliter/minute |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) spine | 6.32 milliliter/minute |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) upper extremities | 3.70 milliliter/minute |
| Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP) whole skeleton | 38.30 milliliter/minute |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) lower extremities | 7.09 percentage of uptake |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) mandible | 0.14 percentage of uptake |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) pelvis | 4.57 percentage of uptake |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) skull | 2.59 percentage of uptake |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) spine | 4.85 percentage of uptake |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) upper extremities | 2.98 percentage of uptake |
| Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP) whole skeleton | 29.4 percentage of uptake |
| Weight | 63.80 kilogram STANDARD_DEVIATION 13.56 |
| Years post menopause | 21.84 years STANDARD_DEVIATION 7.65 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months
Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).
Time frame: baseline, 18 months
Population: All participants with a baseline observation and at least 1 post-baseline observation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Teriparatide | Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months | 33.75 percentage of change of plasma clearance |
Comparison: Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.p-value: 0.002Wilcoxon signed rank test
Secondary
Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton
Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting \<1% of skeleton; 2=focal areas affecting \>=5% of skeleton; 3=focal areas affecting \>=20% of skeleton; 4=focal areas affecting \>=50% of skeleton.
Time frame: Baseline, 3 months, 18 months, 24 months
Population: All participants with a baseline observation and at least 1 post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Teriparatide | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | focal change, baseline to 3 months, n=10 | 0.1 units on a scale | Standard Deviation 0.32 |
| Teriparatide | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | focal change, baseline to 18 months, n=10 | 0.1 units on a scale | Standard Deviation 0.32 |
| Teriparatide | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | focal change, baseline to 24 months, n=9 | 0 units on a scale | Standard Deviation 0 |
| Teriparatide | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | focal change, 3 months to 18 months, n=10 | 0 units on a scale | Standard Deviation 0 |
| Teriparatide | Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton | focal change, 18 months to 24 months, n=9 | 0 units on a scale | Standard Deviation 0 |
Comparison: Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.p-value: 1Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.p-value: 1Wilcoxon signed rank test
Secondary
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.
Time frame: Baseline, 3 months, 18 months, 24 months
Population: All participants with a baseline observation and at least 1 post-baseline observation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Whole skeleton, baseline to 3 months, n=10 | 25.02 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Upper extremities, 18 months to 24 months, n=9 | -19.35 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Whole skeleton, baseline to 24 months, n=9 | 3.52 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Whole skeleton, 3 months to 18 months, n=10 | 10.44 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Whole skeleton, 18 months to 24 months, n=9 | -22.20 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Skull, baseline to 3 months, n=8 | 72.25 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Skull, baseline to 18 months, n=8 | 128.44 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Skull, baseline to 24 months, n=7 | 21.20 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Skull, 3 months to 18 months, n=8 | 31.01 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Skull, 18 months to 24 months, n=7 | -37.87 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Mandible, baseline to 3 months, n=8 | 65.94 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Mandible, baseline to 18 months, n=8 | 60.99 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Mandible, baseline to 24 months, n=7 | 21.05 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Mandible, 3 months to 18 months, n=8 | 4.55 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Mandible, 18 months to 24 months, n=7 | -17.39 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Spine, baseline to 3 months, n=10 | 17.31 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Spine, baseline to 18 months, n=10 | 33.81 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Spine, baseline to 24 months, n=9 | 16.94 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Spine, 3 months to 18 months, n=10 | 14.10 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Spine, 18 months to 24 months, n=9 | -9.42 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Pelvis, baseline to 3 months, n=10 | 20.26 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Pelvis, baseline to 18 months, n=10 | 8.36 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Pelvis, baseline to 24 months, n=9 | -5.58 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Pelvis, 3 months to 18 months, n=10 | -3.29 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Pelvis, 18 months to 24 months, n=9 | -13.81 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Upper extremities, baseline to 3 months, n=10 | 42.52 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Upper extremities, baseline to 18 months, n=10 | 95.49 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Upper extremities, baseline to 24 months, n=9 | 62.76 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Upper extremities, 3 months to 18 months, n=10 | 45.84 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Lower extremities, baseline to 3 months, n=10 | 20.98 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Lower extremities, baseline to 18 months, n=10 | 34.88 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Lower extremities, baseline to 24 months, n=9 | 7.07 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Lower extremities, 3 months to 18 months, n=10 | 12.72 percentage of change of plasma clearance |
| Teriparatide | Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | Lower extremities, 18 months to 24 months, n=9 | -20.72 percentage of change of plasma clearance |
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.p-value: 0.0313Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.p-value: 0.0156Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.p-value: 0.0156Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.p-value: 0.1563Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.p-value: 0.4375Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.p-value: 0.0781Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.p-value: 0.0371Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.p-value: 0.0137Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.p-value: 0.0547Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.p-value: 0.0488Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.p-value: 0.3594Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.p-value: 0.0488Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.p-value: 0.1055Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.p-value: 0.9102Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.p-value: 0.1934Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.p-value: 0.1641Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.p-value: 0.0137Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.p-value: 0.002Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.p-value: 0.0039Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.p-value: 0.0273Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.p-value: 0.0547Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.p-value: 0.0195Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.p-value: 0.0059Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.p-value: 0.5703Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.p-value: 0.1934Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.p-value: 0.0039Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.p-value: 0.0039Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.p-value: 0.5703Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.p-value: 0.0273Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.p-value: 0.0039Wilcoxon signed rank test
Secondary
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.
Time frame: Baseline, 3 months, 18 months, 24 months
Population: All participants with a baseline observation and at least 1 post-baseline observation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | spine, baseline to 24 months, n=9 | 17.68 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | spine, 3 months to 18 months, n=10 | 13.36 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | whole skeleton, baseline to 3 months, n=10 | 15.63 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | whole skeleton, baseline to 18 months, n=10 | 26.12 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | whole skeleton, baseline to 24 months, n=9 | 5.68 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | whole skeleton, 3 months to 18 months, n=10 | 3.99 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | whole skeleton, 18 months to 24 months, n=9 | -14.54 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | skull, baseline to 3 months, n=8 | 68.27 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | skull, baseline to 18 months, n=8 | 120.85 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | skull, baseline to 24 months, n=7 | 26.87 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | skull, 3 months to 18 months, n=8 | 23.63 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | skull, 18 months to 24 months, n=7 | -34.36 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | mandible, baseline to 3 months, n=8 | 52.20 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | mandible, baseline to 18 months, n=8 | 62.91 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | mandible, baseline to 24 months, n=7 | 23.08 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | mandible, 3 months to 18 months, n=8 | 3.85 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | mandible, 18 to 24 months, n=7 | -6.25 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | spine, baseline to 3 months, n=10 | 12.15 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | spine, baseline to 18 months, n=10 | 17.77 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | spine, 18 months to 24 months, n=9 | -0.19 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | pelvis, baseline to 3 months, n=10 | 14.26 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | pelvis, baseline to 18 months, n=10 | -1.21 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | pelvis, baseline to 24 months, n=9 | -1.48 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | pelvis, 3 months to 18 months, n=10 | -3.70 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | pelvis, 18 months to 24 months, n=9 | -5.23 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | upper extremities, baseline to 3 months, n=10 | 31.59 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | upper extremities, baseline to 18 months, n=10 | 76.58 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | upper extremities, baseline to 24 months, n=9 | 57.82 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | upper extremities, 3 months to 18 months, n=10 | 48.58 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | upper extremities, 18 months to 24 months, n=9 | -10.13 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | lower extremities, baseline to 3 months, n=10 | 9.25 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | lower extremities, baseline to 18 months, n=10 | 23.98 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | lower extremities, baseline to 24 months, n=9 | 0.86 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | lower extremities, 3 months to 18 months, n=10 | 7.58 percentage of change of skeletal uptake |
| Teriparatide | Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities | lower extremities, 18 months to 24 months, n=9 | -16.99 percentage of change of skeletal uptake |
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.p-value: 0.0098Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.p-value: 0.0039Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.p-value: 0.6523Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.p-value: 0.1641Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.p-value: 0.0781Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.p-value: 0.0078Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.p-value: 0.0156Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.p-value: 0.0391Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.p-value: 0.0313Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.p-value: 0.2969Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.p-value: 0.5625Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.p-value: 0.0469Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.p-value: 0.1934Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.p-value: 0.2324Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.p-value: 0.0645Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.p-value: 0.0273Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.p-value: 0.7344Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.p-value: 0.1934Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.p-value: 0.7695Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.p-value: 0.6523Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.p-value: 0.2324Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.p-value: 0.6523Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.p-value: 0.0098Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.p-value: 0.002Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.p-value: 0.0039Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.p-value: 0.0273Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.p-value: 0.3594Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.p-value: 0.0371Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.p-value: 0.0098Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.p-value: 0.4609Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.p-value: 0.1934Wilcoxon signed rank test
Comparison: Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.p-value: 0.0273Wilcoxon signed rank test
Secondary
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.
Time frame: baseline, 3 months, 18 months, 24 months
Population: All participants with a baseline observation and at least 1 post-baseline observation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 24 months, definite response | 1 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 3 months, no response | 2 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 3 months, possible response | 2 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 3 months, definite response | 6 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 18 months, no response | 1 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 18 months, possible response | 1 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 18 months, definite response | 8 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 24 months, possible response | 1 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 24 months, no response | 6 participants |
| Teriparatide | Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton | 24 months, possible response | 1 participants |