Trial · NCT03027557
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Lumbar Spine Bone Mineral Density | Baseline,one year | Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Change in Total Hip Bone Mineral Density | Baseline,one year | Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Change in Femoral Neck Bone Mineral Density | Baseline,one year | Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Change in 1/3 Forearm Bone Mineral Density | Baseline,one year | Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Percentage Change in Lumbar Spine Bone Mineral Density | Baseline,one year | Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Percentage Change in Total Hip Bone Mineral Density | Baseline,one year | Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Percentage Change in Femoral Neck Bone Mineral Density | Baseline,one year | Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Primary | Percentage Change in 1/3 Forearm Bone Mineral Density | Baseline,one year | Percentage change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan. |
| Secondary | Change in Volumetric BMD for the Lumbar Spine. | Baseline, one year | Measured at baseline and after one year by QCT. |
| Secondary | Mean P-calcium During Treatment. | Monthly up to one year. | Blood samples were acquired once every 4 weeks for safety-purposes. |
| Secondary | Percent Change From Baseline in P-carboxy-terminal Collagen Crosslinks (CTX) | Change from baseline at 48 weeks reported. | p-CTX, change from baseline at 48 weeks. |
| Secondary | Median Agatstons Score Final | Baseline, one year | Simultaneously with QCT-measurements coronary calcification was be assessed. Agatston score is a score based on the extent of coronary artery calcification calculated on the amount of plaque observed in a CT scan. A score of zero indicates absence of coronary calcium, 1-10: minimal calcification, 11-100 mild calcification, 101-400 moderate calcification, \>400 severe calcification. Thus the score increases with increasing level of calcification in the coronary vessels. |
| Secondary | Patients With Nephrolithiasis Final Scan. | Patients with nephrolithiasis at one year reported. | Number of subjects w. renal stones at final scan. |
| Secondary | Patients With Pancreas-calcifications Final Scan. | Patients with pancreas-calcifications at one year reported. | By QCT. |
| Secondary | Reset of the Calcium Sensing Receptor? | 2 weeks after termination of medication. | Measured from effect on s-calcium and PTH weeks after termination of IMP |
| Secondary | Vertebral Fracture Assessment - Final Scan | Patients with vertebral fractures at one year reported. | Number of participants with vertebral fractures as assessed by VFA at final scan. |
| Secondary | Change MDI-score | Baseline, 6 mths, one year. | Major Depression Inventory (MDI)-score, Baseline, 6 months, one year (week 52)., change between baseline and 1 year reported. The Major Depression Inventory (MDI) is a mood questionnaire developed by the World Health Organization. To calculate the total score, a sum of ten individual items (each with an individual score between 0-5, with 0 indicating absence of a symptom and 5 indicating constant presence of a given symptom) is used. A higher score signifies deeper depression with 50 being the maximum score. |
| Secondary | Adverse Reactions. | Monthly up to one year. | All participants filled in questionnaires regarding symptoms related to the treatment. Results are reported in the Adverse Events section. |
| Secondary | Bone Mineral Content | Baseline, one year | Measured at baseline and after one year at the lumbar spine and distal 1/3 of the non-dominant antebrachii. |
| Secondary | Change in Cortical Width. | Baseline, one year. | Measured at baseline and after one year at the distal non-dominant antebrachii. |
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
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