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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

Overview

Status
Completed
Phase
Phase 3
Enrollment
23 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
20 Sept 2018
Primary completion
15 Jul 2020
Completion
15 Jul 2020
First posted
18 Oct 2018
Last update posted
15 Oct 2021
Conditions
Osteoporosis, Postmenopausal · Osteoporosis · Osteoporosis Vertebral · Osteoporosis Risk · Osteoporosis Fracture · Osteoporosis Localized to Spine · Osteoporosis, Age-Related · Osteoporosis Senile · Osteoporosis of Vertebrae

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 3

    Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

    NCT03710889

    20 Sept 2018 to 15 Jul 2020

Registry summary

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

The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.

Interventions

  • AbaloparatideDrug

Arms1

  • Experimental

    Abaloparatide

    Participants self-administered a single daily dose of 80 micrograms (µg) of abaloparatide subcutaneously (SC) during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3

    Time frame · Baseline (Day 1), Month 3

    Registry description

    Change in dynamic histomorphometry indices was assessed in the cancellous envelope.

Secondary outcomes(3)
  1. Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3

    Time frame · Baseline (Day 1), Month 3

    Registry description

    Change in dynamic histomorphometry indices was assessed in the cancellous envelope. BFR/BS was reported as cubic millimeter/square millimeter/year (mm\^3/mm\^2/year).

  2. Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3

    Time frame · Baseline (Day 1), Months 1 and 3

    Registry description

    Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3.

  3. Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3

    Time frame · Baseline (Day 1), Months 1 and 3

    Registry description

    Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3.

Posted results

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

Primary outcome results

Primary outcomeMean· Baseline (Day 1), Month 3

Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3

GroupValue (percentage of MS/BS)Spread
Abaloparatide5.743.978
Secondary and other outcome results(3)
Secondary outcomeMean· Baseline (Day 1), Month 3

Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3

GroupValue (mm^3/mm^2/year)Spread
Abaloparatide0.0110.0076
Secondary outcomeMedian· Baseline (Day 1), Months 1 and 3

Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3

GroupValue (nanograms (ng)/milliliter (mL))
Abaloparatide54.990
Secondary outcomeMedian· Baseline (Day 1), Months 1 and 3

Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3

GroupValue (ng/mL)
Abaloparatide0.460

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AbaloparatideParticipants self-administered a single daily dose of 80 µg of abaloparatide SC during the treatment period. Participants were instructed to use a new injection pen after each 30-day period.0 / 232 / 2318 / 23

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Clinical trial · 2021

13 results

Early Effects of Abaloparatide on Bone Formation and Resorption Indices in Postmenopausal Women With Osteoporosis.

Dempster et al. 2021Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 27

PMID 33434314PMC8248188DOI 10.1002/jbmr.4243PUB-33434314

CC BY13 results

Indexing hint: Randomized controlled trial · 2017

7 results

Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial.

Cosman et al. 2017Mayo Clinic proceedingscited by 96

PMID 28160873DOI 10.1016/j.mayocp.2016.10.009PUB-28160873

Free to read · publisher termsCC BY-NC-ND7 results

Indexing hint: Observational study · 2016

2 results

Binding Selectivity of Abaloparatide for PTH-Type-1-Receptor Conformations and Effects on Downstream Signaling.

Hattersley et al. 2016Endocrinologycited by 231

PMID 26562265PMC4701881DOI 10.1210/en.2015-1726PUB-26562265

Rights unknown2 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria Participants must meet all of the following criteria to be eligible to participate in this study: 1. The participant is a healthy ambulatory postmenopausal female from 50 to 85 years of age (inclusive) with osteoporosis. 2. The participant has been postmenopausal for at least 5 years. Postmenopausal status will be established by a history of amenorrhea for at least 5 years and by an elevated follicle stimulating hormone (FSH) value of ≥30 international units(IU)/liter (L). 3. The participant has a BMD T-score ≤-2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual-energy x-ray absorptiometry (DXA) or lumbar spine or hip BMD T-score ≤-2.0 with a history of low trauma vertebral, forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture sustained within 5 years prior to enrollment. These fractures must be documented by radiograph or hospital report. 4. The participant is in good general health as determined by medical history and physical examination (including vital signs), has a body mass index (BMI) of 18.5 to 33, inclusive, and is without evidence of clinically significant abnormality in the opinion of the Investigator. 5. The participant has serum calcium (albumin-corrected), parathyroid hormone (PTH) (1-84), phosphorus, and alkaline phosphatase levels all within the normal range during the Screening Period. Any participant with an elevated alkaline phosphatase value, and who meets all other entry criteria, is required to have a normal bone-specific alkaline phosphatase result to be enrolled. 6. The participant has serum 25-hydroxyvitamin D values ≥ 20 nanograms (ng)/milliliter (mL) and within the normal range. Participants with serum 25-hydroxyvitamin D levels \< 20 ng/ml may be treated with vitamin D3 and re-tested once. 7. The participant's resting 12-lead electrocardiogram (ECG) obtained during screening shows no clinically significant abnormality. 8. The participant has read, understood, and signed the written informed consent form. Exclusion Criteria: Participants with any of the following characteristics are not eligible to participate in the study: 1. Presence of abnormalities of the lumbar spine that would prohibit assessment of lumbar spine BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4. 2. Unevaluable hip BMD or participants who have undergone bilateral hip replacement (unilateral hip replacement is acceptable). 3. History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis. 4. Clinically significant abnormality of serum hemoglobin, hematocrit, white blood cells (WBC) and platelets, coagulation, or usual serum chemistry: electrolytes, renal function, liver function and serum proteins. 5. Unexplained elevation of serum alkaline phosphatase. 6. History of radiotherapy (radiation therapy), other than radioiodine. 7. History of bleeding disorder that would preclude a bone biopsy, in the opinion of the Investigator. 8. History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the participant. 9. History of Cushing's disease, hyperthyroidism, hypo- or hyperparathyroidism, or malabsorptive syndromes within the past year. 10. History of significantly impaired renal function (serum creatinine \> 177 micromoles \[µmol\]/L or \>2.0 milligrams \[mg\]/deciliter \[dL\]). If the serum creatinine is \>1.5 and ≤ 2.0 mg/dL, the calculated creatinine clearance (Cockcroft-Gault) must be ≥ 30 mL/minute (min). 11. History of any cancer within the past 5 years (other than basal cell or squamous cell cancer of the skin). 12. History of osteosarcoma at any time or a history of hereditary disorders which could predispose the participant to osteosarcoma. 13. History of nephrolithiasis or urolithiasis within the past 5 years. 14. Participant known to be positive for hepatitis B, hepatitis C, or human immunodeficiency virus infection (HIV-1 or HIV-2). Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis.

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