Denosumab Switch for Osteoporosis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and 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).

Research Team

Eligibility Criteria

This trial is for men and women aged 18 or older who have been using glucocorticoids at a certain dose for over 3 months and will continue for at least another six. They must have osteoporosis as shown by bone density scores, or a history of fractures with less severe bone loss. Exclusions include various other bone diseases, recent cancer, dental issues, malnutrition disorders, pregnancy/breastfeeding without contraception use, and intolerance to study drugs.

Inclusion Criteria

I have been taking a steroid medication equivalent to more than 7.5 mg of prednisone daily for over 3 months and will continue for at least 6 months.

My bone density is low, or I've had a fracture due to weak bones.

I am 18 or older and can give my consent.

Exclusion Criteria

I have been diagnosed with Addison's disease.

Not a good candidate for study participation in opinion of investigator

I cannot take denosumab due to bad reactions or allergies.

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Treatment Details

Interventions

Denosumab (Monoclonal Antibodies)

Trial OverviewThe study tests if switching from Denosumab (DMAB) to 'late' zoledronic acid (9 months after last DMAB dose) versus 'early' zoledronic acid (6 months after last DMAB dose) or weekly alendronate affects bone turnover markers in patients on long-term steroids differently.

Participant Groups

3Treatment groups

Active Control

Group I: DMAB to "Early" Zoledronic Acid (ZA)Active Control1 Intervention

Switch from Denosumab 60 mg administered subcutaneously (SC) to one "early" zoledronic acid infusion (5 mg; 6 months after last denosumab dose)

Group II: Denosumab (DMAB) to Alendronate (ALN)Active Control1 Intervention

Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate (70 mg; started 6 months after last denosumab dose)

Group III: DMAB to "Late" ZAActive Control1 Intervention

Switch from Denosumab 60 mg administered subcutaneously (SC) to one "late" zoledronic acid infusion (5 mg; 9 months after last denosumab dose)

Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Prolia for:

Osteoporosis in postmenopausal women
Bone loss associated with hormone ablation therapy for prostate cancer
Bone loss associated with hormone ablation therapy for breast cancer

🇺🇸 Approved in United States as Prolia for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

🇨🇦 Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture

🇯🇵 Approved in Japan as Prolia for: