Clinical trial NCT05091086: The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
Official title: The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Osteoporosis
Bone Mineral Density
Keywords: Osteoporosis
denosumab
zoledronic acid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel group would be selected. One group of participants keep their denosumab treatment for 7 years. Another group of participants accept two cycles of treatment (one year of zoledronate and two years of denosumab) and complete with one year of zoledronate.
Primary purpose: TREATMENT

Brief summary: This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

Detailed description: This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
2. Denosumab treatment for at least two years and less than three years (up to maximum of five doses).

Exclusion Criteria:

1. Secondary osteoporosis.
2. Metabolic bone diseases.
3. Malignancy.
4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
5. Patients had ever used antiosteoporosis medications other than Dmab
6. Estimated glomerular filtration rate \< 35 mL/min.
7. Allergy to Zoledronate.
8. Any other contraindications to Zoledronate use.
9. History of diagnosed hypocalcemia.
10. Age greater than 80 years.

Primary outcomes:
measure: Change in lumbar spine bone mineral density
timeFrame: From enrollment to the end of treatment at 3 years
Secondary outcomes:
measure: Change in total hip bone mineral density
timeFrame: From enrollment to the end of treatment at 3 years and 7 years
measure: Change in femoral neck bone mineral density
timeFrame: From enrollment to the end of treatment at 3 years and 7 years
measure: Change in lumbar spine bone mineral density
timeFrame: From enrollment to the end of treatment at 7 years
measure: Change in C-terminal telopeptide of type 1 collagen
timeFrame: From enrollment to the end of treatment at 3 years and 7 years
measure: Change in Procollagen type 1 N-terminal propeptide
timeFrame: From enrollment to the end of treatment at 3 years and 7 years
measure: Fractures
timeFrame: 3 & 7 years
measure: Change in quality of life
timeFrame: From enrollment to the end of treatment at 3 years and 7 years
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital, Yunlin branch
state: Yunlin county
Study officials:
References: