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Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Dec 1, 2026 to Dec 31, 2026 Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 1, 2026 to Sep 18, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Publications: details revised at 5 of 5 entries
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Apr 2026 to Sep 1, 2026
    • Study completion date: Jun 2026 to Dec 1, 2026
    • Site details revised
    v6
  4. Collaborators reorderedv5
  5. Lead sponsor: Felicia Cosman, MD to Hospital for Special Surgery, New York
    • Primary completion date: Jul 2022 to Apr 2026
    • Study completion date: Jan 2023 to Jun 2026
    • Study site revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Lead sponsor: Jacqueline Kernaghan, PA-C to Felicia Cosman, MDv3 Show 7 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2020 to Feb 1, 2021
    • Study sites: 0 to 1
    • Primary completion date: Feb 2022 to Jul 2022
    • Study completion date: Aug 2022 to Jan 2023
    • Study description expanded, about 6 words
    • Eligibility criteria expanded, about 4 words
  2. Lead sponsor: Jacqueline Kernaghan to Jacqueline Kernaghan, PA-C
    • Eligibility criteria shortened, about 29 words
    • Study description expanded, about 4 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months. 70 postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at 18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months. Secondary outcomes will also include within group changes from baseline for each of these variables. Bone turnover markers will also be measured to demonstrate that PINP levels will increase with administration of abaloparatide even in the setting of ongoing denosumab, while CTX levels will remain low.
Trial Details
NCT Number NCT04467983
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: Radius Health, Inc., Crozer-Keystone Health System
Conditions
(from sponsor)		 Osteoporosis, Postmenopausal
Related terms Osteoporosis, Postmenopausal
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov