Trial · NCT00048061
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density | From Baseline (Month 0) to Month 12 | Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis. |
| Secondary | Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | From Baseline (Month 0) to Month 24 | Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24. |
| Secondary | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD | From Baseline (Month 0) to Months 12 and 24 | The absolute change (g/cm\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated. |
| Secondary | Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD | From Baseline (Month 0) to Months 12 and 24 | Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center. |
| Secondary | Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD. | From Baseline (Month 0) to Months 12 and 24 | Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center |
| Secondary | Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. |
| Secondary | Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24 | Months 12 and 24 | A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. |
| Secondary | Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24 | From Baseline (Month 0) to Months 3, 6, 12, 24 | Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). |
| Secondary | Absolute Change In Baseline in Serum CTX to Months 12 and 24 | From Baseline (Month 0) to Months 12 and 24 | Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique). |
| Secondary | Number of Participants With Any Adverse Events and Serious Adverse Event | Up to Month 24 | An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Secondary | Number Of Participants With Marked Laboratory Abnormalities | Up to Month 24 | Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \[umol/L\]. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00048061/registered