Paget's disease of bone Musculoskeletal Diseases
Conditions
Interventions
One arm of the study will receive a probiotic intervention. Probiotics have previously been evidenced to be beneficial to bone health. The probiotic intervention will consist of three lactobacillus st
Sponsors
Accord (United Kingdom)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. Clinical diagnosis of Paget's disease of the bone confirmed by characteristic appearances on radionuclide bone scan and /or x-ray 3. Serum total alkaline phosphatase elevated above the upper limit of normal or within the upper half of the local reference range 4. Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to give informed consent 2. Bisphosphonate therapy thought to be indicated for the treatment of Paget's disease of the bone on clinical grounds 3. Currently being treated with bisphosphonates, denosumab or calcitonin for any reason 4. Currently being treated with combined calcium and vitamin D supplements 5. Treatment with oral or intravenous bisphosphonates during the previous 24 months 6. Treatment with denosumab during the past 12 months 7. Treatment with calcitonin during the previous 3 months. 8. Treatment with combined calcium and vitamin D supplements during the past 4 weeks 9. Receiving probiotics during the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic activity of Paget's disease of the bone assessed by serum concentrations of total alkaline phosphatase measured using an alkaline phosphatase test at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical markers of bone metabolism levels, including PINP, CTX, PTH and 25(OH)D, measured using blood samples collected at baseline, 3 and 6 months 2. Health-related quality of life measured using the 36-Item Short Form Survey (SF-36) at 6 months 3. Presence and severity of pain at sites affected by Paget's disease of the bone measured using a Visual Analogue Scale at baseline, 3 and 6 months 4. Microbiome measured using 16S sequence analysis of stool samples at 3 and 6 months | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactKathryn Berg
Outcome results
None listed