Paget's Disease of Bone Clinical Trial
Official title:
Investigation of Pathophysiology of Angiogenesis and Osteogenesis in Paget's Disease of Bone
Verified date | January 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Paget's disease of the bone is a skeletal disorder which results in increased and disorganized bone remodeling, leading to dense but fragile and expanding bones. The identified genetic causes of Paget's disease of bone only explain why bone is destroyed, but not why the bone formed in its place is abnormal. Current treatment for people with Paget's disease of the bone is limited to patients with bone pain, thought to be related to high rate of bone turnover (breakdown and rebuilding of bone) and works by slowing down the rate of bone breakdown. The current treatment does not address the excess blood vessels and bone formed. This research is being done to understand factors that may promote blood vessel and bone formation in Paget's disease of the bone.
Status | Active, not recruiting |
Enrollment | 11 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria for Cases: - Men and women between the ages of 18-99 years who have evidence of active Paget's disease of bone as clinically and/or radiographically defined by: - Increased serum alkaline phosphatase or increased serum collagen type 1 c-telopeptide (CTX) or increase in urinary pyridinoline at diagnosis - AND history of at least one of the following signs/symptoms: Pagetoid lesions(s) on x-ray/CT/MRI, increased uptake of radioactive substance by bone scan, bone pain, fracture, hearing loss, headache, hypercalcemia, or bony deformity. Inclusion criteria for controls: - Men and women between the ages of 18-99 years who match age within 5 years of cases and gender who do NOT have evidence of Paget's disease of bone as defined by: - No bone pain or bony deformity - Normal serum alkaline phosphatase Exclusion Criteria: - Osteosarcoma or other blastic bony metastases alone - Fibrous dysplasia of bone - Hyperostosis frontalis interna - All men and women < 18 years or > 99 years - Pregnancy (women) determined by self-report - Current use of oral contraceptive tablets or Depo-Provera™ (women) - Current use of hormone replacement therapy - Creatinine clearance < 60 ml/min./1.73 m2 by Cockcroft-Gault based on most recent serum creatinine level (if greater than 1 year since last assessment, will be measured on collected blood sample to verify eligibility) - Current smoking or tobacco use - Alcohol use greater than 3 units daily - Use of thiazolidinediones within the last year - Use of medications known to impact bone and mineral metabolism, including use of a bisphosphonate in the last 11 months; ever use of teriparatide or denosumab; use of calcitonin, selective estrogen receptor modulators (SERMs), or estrogen within the past 6 months, prednisone > 5 mg for over 10 days in the last three months, anti-epileptic medications (e.g. phenytoin, carbamezapine, phenobarbitol, and primidone); current or use within the past year of aromatase inhibitors; leuprolide; histrelin - History of a thyroid problem that is currently uncontrolled as defined by most recent thyroid stimulating hormone levels < 0.1 microIU/mL (if greater than 6 months since last assessment, will be measured on collected blood sample to verify eligibility) - Other known metabolic or structural bone disease other than low bone density (e.g. hyperparathyroidism, multiple myeloma, sarcoid or other granulomatous disease, celiac disease, osteopetrosis, osteomalacia, osteitis fibrosa cystica) - Other significant medical illness (heart disease, pulmonary disease, inflammatory bowel disease, malignancy other than ductal carcinoma in situ (DCIS) or non-melanoma skin cancer, rheumatologic conditions including rheumatoid arthritis, systemic lupus, renal disease requiring dialysis, etc.) - Inability to understand and provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum chemokine level | Compare the serum chemokine concentrations in research participants with Paget's disease of bone to research participants without Paget's disease of bone | Day 1 | |
Secondary | Correlation of chemokine level to Paget's Disease of Bone Pain | Correlate the serum chemokine concentration in research participants with Paget's disease of bone to burden of disease as assessed clinically by pain utilizing the Likert pain scale. | Day 1 | |
Secondary | Correlation of chemokine level to alkaline phosphatase concentration | Correlate the serum chemokine concentration in research participants with Paget's disease of bone to burden of disease as assessed clinically by serum alkaline phosphatase concentration. | Day 1 | |
Secondary | Correlation of chemokine level to proportion of affected skeleton | Correlate the serum chemokine concentration in research participants with Paget's disease to percent of skeleton affected as assessed radiographically by bone scan and x-ray. | Day 1 | |
Secondary | Correlation of chemokine level to number of circulating stem cells | Correlate the serum chemokine concentration in research participants to number of circulating mesenchymal stem cell and epithelial progenitor cells. | Day 1 |
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