Trial · Interventional

Active, not recruitingPhase 4Registry data

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

NCTNCT04467983Other id2022-1296

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 4
Enrollment: 70 participants (estimated)
Sponsor: Hospital for Special Surgery, New York · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Feb 2021
Primary completion: 18 Sept 2026
Completion: 31 Dec 2026 (estimated)
First posted: 13 Jul 2020
Last update posted: 13 Oct 2026
Conditions: Osteoporosis, Postmenopausal

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024202520262027

Ph 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
NCT04467983
1 Feb 2021 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Denosumab InjectionDrug
AbaloparatideDrug

Arms2

Active comparator
Denosumab alone
3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
Active comparator
Combination therapy
3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

Bone mineral density changes at total hip and lumbar spine
Time frame · 18 months
Registry description
Group differences in BMD increment at total hip and lumbar spine at 18 months.

Secondary outcomes(4)

Bone mineral density changes in increments
Time frame · 6, 12, 18 months
Registry description
Group Differences in BMD increments: of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months. Group Differences in BMD increments: of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months. Group Differences in BMD increments: of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months. Group differences in BMD increments of lumbar spine and total hip (at 6 and 12 months) and of femoral neck and 1/3 distal radius (at 6, 12, and 18 months)
Trabecular Bone Score changes
Time frame · 18 months
Registry description
Group differences in Trabecular Bone Score at 18 months
Within Group Increments in bone mineral density (vs baseline)
Time frame · 6, 12, 18 months
Registry description
Within Group Increments in bone mineral density vs baseline of lumbar spine (at 6, 12, and 18 months) and of total hip, femoral neck, and distal 1/3 radius (at 6, 12, and 18 months)
Differences in biochemical bone turnover markers
Time frame · 3, 6, 12, 18 months
Registry description
Within and between group differences in biochemical bone turnover markers (P1NP and CTX) at 3, 6, 12, and 18 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2015

7 results

Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis.

Leder et al. 2015The Journal of clinical endocrinology and metabolismcited by 193

PMID 25393645DOI 10.1210/jc.2014-3718PUB-25393645

Rights unknown7 results

Source link See results (7)

Indexing hint: Randomized controlled trial · 2015

18 results

Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial.

Leder et al. 2015Lancet (London, England)cited by 426

PMID 26144908PMC4620731DOI 10.1016/s0140-6736(15)61120-5PUB-26144908

Rights unknown18 results

Source link See results (18)

Indexing hint: Randomized controlled trial · 2014

11 results

Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial.

Leder et al. 2014The Journal of clinical endocrinology and metabolismcited by 196

PMID 24517156PMC4010689DOI 10.1210/jc.2013-4440PUB-24517156

Rights unknown11 results

Source link See results (11)

Indexing hint: Randomized controlled trial · 2013

14 results

Hip and spine strength effects of adding versus switching to teriparatide in postmenopausal women with osteoporosis treated with prior alendronate or raloxifene.

Cosman et al. 2013Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 66

PMID 23281041DOI 10.1002/jbmr.1853PUB-23281041

Rights unknown14 results

Source link See results (14)

Indexing hint: Randomized controlled trial · 2009

14 results

Effects of teriparatide in postmenopausal women with osteoporosis on prior alendronate or raloxifene: differences between stopping and continuing the antiresorptive agent.

Cosman et al. 2009The Journal of clinical endocrinology and metabolismcited by 127

PMID 19584192DOI 10.1210/jc.2008-2719PUB-19584192

Rights unknown14 results

Source link See results (14)

Eligibility

Who could join, as posted.

Sex: Female
Age: from 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * postmenopausal woman \>age 45 of any racial origin * Participants will have received at least 4 prior denosumab treatments and be within 7 months from their last denosumab injection * Participants are willing to participate for the duration of the study and have no physical or psychological illness that would prohibit them from participating. * Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria. Osteoporosis will be defined by bone mineral density T-Score \< -2.5 at lumbar spine (at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck. Osteoporosis will also be defined clinically in women with osteoporotic fractures within the preceding 5 years, including clinical vertebral or nonvertebral fractures or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a DXA BMD T-Score \< -1.5 at one or more skeletal sites. Exclusion Criteria: * Use of drugs other than denosumab (within the preceding 3 months) known to affect skeletal or calcium homeostasis. * Fewer than 2 evaluable lumbar vertebrae * A history of a symptomatic renal stone within the past 2 years or history of multiple symptomatic renal stones within the preceding 10 years * Skeletal Disorders other than osteoporosis, including hypercalcemia, hyperparathyroidism, or Paget's Disease * History of external or internal radiation therapy * Estimated GFR below 30 ml/min * Any contraindications to receipt of Abaloparatide or Denosumab * History of any cancer in past 5 years (except basal/squamous skin cancer) * Unexplained elevation of Serum Alkaline Phosphatase * History of atypical femoral fracture

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