Glucocorticoid-Induced Osteoporosis (GIOP)
Conditions
Interventions
Product Name: Alendronato
Product Code: [Alendronato]
Pharmaceutical Form: Tablet
INN or Proposed INN: ACIDO ALENDRONICO
CAS Number: 121268-17-5
Current Sponsor code: OPR000000528
Other descriptive na
Sponsors
University of Alabama at Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Women and men, age 18 years or older and able to provide informed consent (IC) = 3 months of glucocorticoid use at > 7.5 mg /day (prednisone equivalent dose) and anticipated to remain on glucocorticoids for at least six months A baseline BMD T-score of = -1.0 at the lumbar spine, total hip, or femoral neck (prior to denosumab use if prevalent user) - previous doses of densoumab (for prevalent users) must be continuous and not separated by interval greater than 8 months. If interval between denosumab doses is greater than 8 months, the participant is considered a new user Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients with fewer than three lumbar vertebrae that could be evaluated on dual energy x-ray absorptiometry (DXA) No past IV bisphosphonates. Oral bisphosphonates must not have been taken in the past 2 months and for no more than 2 consecutive months of use in the past year (e.g. 8 total weekly doses of alendronate maximum) Greater than 24 months (>4 injections) of prior treatment with denosumab Women of childbearing potential, who are not currently using birth control, are pregnant, planning to become pregnant, or are breastfeeding. For women of childbearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication* Men planning to conceive in the next 12 months Unstable systemic medical condition Uncontrolled hyperthyroidism Uncontrolled hypothyroidism History of Addison disease History of osteomalacia History of osteonecrosis of the jaw (ONJ) History of atypical femur fracture History of tooth extraction, jaw surgery, dental implants, or other dental surgery within the prior 6 months History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition. Invasive dental work(implants/surgery) planned in the next 2 years History of Paget's disease of bone Other bone diseases which affect bone metabolism Vitamin D deficiency [25(OH) vitamin D level 10% above upper limit of normal (ULN) Elevated transaminases or total bilirubin = 2.0 x ULN History of any solid organ or bone marrow transplant Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma or localized squamous cell carcinoma of the skin) Hypocalcemia <10% below lower limit of normal (LLN) Estimated glomerular filtration rate < 30 mL/minute/1.73 m^2 Intolerance to calcium supplements, vitamin D supplements Contraindication to, or poorly tolerant of denosumab therapy (including hypersensitivity to the drug) Contraindication to, or poorly tolerant of zoledronic therapy (including hypersensitivity to the drug) Contraindication to, or poorly tolerant of alendronate (including hypersensitivity to the drug and sever gastro-intestinal intolerance to oral bisphosphonates) Recipient of an investigational drug within 4 weeks prior to study drug administration Not a good candidate for study participation in opinion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that an increase in bone turnover markers (e.g. sum C-terminal telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP)) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose).;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is log of the absolute difference in CTX values between randomization (V4) and 6 months after randomization (V6);Timepoint(s) of evaluation of this end point: The primary end point will be evaluated six months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in the log-transformed CTX between 6 months (V6) and 12 months (V7) Percentage change in the log-transformed CTX 12 months (V7) post randomization P1NP absolute change (µg/mL) 6 months (V6) post randomization P1NP percent change (µg/mL) 12 months (V7) post randomization BMD at spine absolute and percent change (g/cm2) 12 months (V7) post randomization BMD at total-hip absolute and percent change (g/cm2) 12 months (V7) post randomization BMD at femoral neck absolute and percent change (g/cm2) 12 months (V7) post randomization ;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated between 6 and 12 months post randomization | — |
Countries
Belgium, Italy, Netherlands, United States
Contacts
Public ContactDavide Gatti
Università di Verona
Outcome results
None listed