Trial · NCT04303026
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 | Mean change in joint pain by VAS (Visual analogue pain scale from 1-10) from baseline to 12 months follow up, in the intervention group compared to the placebo group | Baseline and 12 months | Pain during weight bearing measured with Visual Analogue Pain Scale |
| Secondary | Mean change in joint pain by VAS from baseline to 3 and 6 months follow up, in the intervention group compared to the placebo group | baseline, 3 and 6 months | Pain during weight bearing measured with Visual Analogue Pain Scale |
| Secondary | Mean change in function and activity score (HOOS) from baseline to 3, 6 and 12 months follow up, in the intervention group compared to the placebo group | baseline, 3, 6 and 12 months | Function and activity measured with PROM (patient reported outcome measure) Hip Disability and Osteoarthritis, 0-100 worst to best scale |
| Secondary | Mean change in function and activity score (HHS) from baseline to 12 months follow up, in the intervention group compared to the placebo group | 12 months | Function and activity measured with Harris hips score, 0-100 worst to best score. |
| Secondary | Mean change in 40mWT (40 meter walking test measured in seconds) from baseline to 3, 6 and 12 months follow up, in intervention group compared to placebo group | baseline, 3, 6 and 12 months | 40 meter walking test measured in seconds |
| Secondary | Mean change in SCT (Stair climb test measured in seconds) from baseline to 3, 6 and 12 months follow up, in intervention group compared to placebo group | baseline, 3, 6 and 12 months | Stair Climb test measured in seconds (11 stairs) |
| Secondary | Mean change in 30CST (Chair stand test, measured by number of repetitions in 30 seconds) from baseline to 3, 6 and 12 months follow up, in intervention group compared to placebo group | baseline, 3, 6 and 12 months | Chair stand test measured in number of repetitions in 30 seconds |
| Secondary | Mean change in QoL (EQ-5D) from baseline to 3, 6 and 12 months follow up, in the intervention group compared to the placebo group | baseline, 3, 6 and 12 months | Use of Euroqol 5 questions (EQ-5D), measuring disease related quality of life. Score is calculated using value set from English population |
| Secondary | Change in mean number of doses of Paracetamol, NSAID and/or opiates per week in each group during the last month compared to baseline at 12 months follow up | baseline, 3, 6 and 12 months | Change in use of pain medication |
| Secondary | Number of AE/SAE (adverse events and serious adverse events) and AR/SAR/SUSAR (adverse/serious adverse and suspected unexpected serious adverse reactions) in the intervention group compared to placebo group 12 months after first infusion. | baseline and 12 months | Registrating number of adverse effects and adverse reactions |
| Other | Change in joint space narrowing (in millimeters) from baseline to 12 months follow up seen on X-ray, compared to the placebo group. | Baseline and 12 months | exploratory endpoint |
| Other | Changes in bone turnover in BMLs after treatment with zoledronic acid seen with histomorphometry. A comparison between patients in the treatment and placebo group, that end up with joint implant surgery. | Baseline and 12 months | Exploratory endpoint. Bone turnover will be assessed after tetracycline double labeling followed by intersection counting of single and double labeled surfaces. |
| Other | Changes in vascularization in BMLs after treatment with zoledronic acid seen with histomorphometry. A comparison between patients in the treatment and placebo group, that end up with joint implant surgery. | Baseline and 12 months | Exploratory endpoint. Tissue vascularity will be assessed using point counting. |
| Other | Changes in bone material properties by impact microindentation (measured in bone material strength index, BMSi) of tibial bone before and after treatment with zoledronic acid compared to the placebo group | Baseline and 12 months | Exploratory endpoint |
| Other | Correlation between bone material properties by impact microindentation of tibial bone (BMSi) and Bone turnover markers (BTM)/BML at baseline comparing patient with and without BMLs on hip MRI | Baseline | Exploratory endpoint |
| Other | Percentage of participants treated with implant surgery of the affected hip in the treatment group compared to placebo group 12 months after the first infusion. | 12 months | Exploratory endpoint |
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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GET https://conductscience.org/api/trials/v1/NCT04303026/registered