Osteoporosis, Primary Hyperparathyroidism
Conditions
Keywords
zoledronic acid, denosumab, primary hyperparathyroidism, osteoporosis
Brief summary
Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.
Interventions
denosumab 60 mg subcutaneously every 6 months
DRUGZoledronic Acid
zoledronic acid 5 mg intravenously once a year
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women (\>12 months after last menstrual period) with primary hyperparathyroidism and with osteoporosis on Dual Energy Xray Absorptiometry (DXA) (according to International Society for Clinical Densitometry (ISCD) - criteria) and/or osteoporotic fracture of the vertebra or hip
Exclusion criteria
* The patient is not able to give informed consent * other classic complications of primary hyperparathyroidism (e.g. kidney stones, renal insufficiency) * serum albumin-corrected calcium level \> 2.85 mmol/L (except when the patient is reluctant to undergo surgical treatment) * osteoporosis treatment less than a year ago, less than two years ago in the case of oral bisphosphonate, less than three years ago in the case of parenteral bisphosphonate * bilateral hip endoprosthesis * additional causes for secondary osteoporosis (other than vitamin D deficiency) and pathological laboratory findings that are incompatible with the Summary of Product Characteristics (SmPC) of both medicines * cancer, except if in stable remission of more than 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density after one year of treatment | one year | Dual-energy X-ray absorptiometry (DXA) |
| CTX after 3 months of treatment | 3 months | Unit of Measure: pmol/L |
| Corrected calcium after 3 months of treatment | 3 months | Unit of Measure: mmol/L |
| Bone mineral density after two years of treatment | two years | Dual-energy X-ray absorptiometry (DXA) |
| CTX after 12 months of treatment | one year | Unit of Measure: pmol/L |
| CTX after 24 months of treatment | two years | Unit of Measure: pmol/L |
| PINP after 3 months of treatment | 3 months | Unit of Measure: µg/L |
| PINP after 12 months of treatment | one year | Unit of Measure: µg/L |
| PINP after 24 months of treatment | two years | Unit of Measure: µg/L |
| Bone-specific alkaline phosphatase (BAP) after 3 months of treatment | 3 months | Unit of Measure: µg/L |
| Bone-specific alkaline phosphatase (BAP) after 12 months of treatment | one year | Unit of Measure: µg/L |
| Bone-specific alkaline phosphatase (BAP) after 24 months of treatment | two years | Unit of Measure: µg/L |
| Corrected calcium after 12 months of treatment | one year | Unit of Measure: mmol/L |
| Corrected calcium after 24 months of treatment | two years | Unit of Measure: mmol/L |
Countries
Slovenia
Outcome results
None listed