Osteoporosis, PostmenopausalPhase 3NCT03710889
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
A Phase 3 study testing Abaloparatide in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Radius Health, Inc. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral
- What is being tested?
- Abaloparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Sep 2018to 15 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible to participate in this study:
- The participant is a healthy ambulatory postmenopausal female from 50 to 85 years of age (inclusive) with osteoporosis.
- 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).
- 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.
- 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.
- 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.
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- 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.
- The participant's resting 12-lead electrocardiogram (ECG) obtained during screening shows no clinically significant abnormality.
- The participant has read, understood, and signed the written informed consent form.
Who cannot join
- Participants with any of the following characteristics are not eligible to participate in the study:
- 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.
- Unevaluable hip BMD or participants who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
- History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
- 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.
- Unexplained elevation of serum alkaline phosphatase.
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- History of radiotherapy (radiation therapy), other than radioiodine.
- History of bleeding disorder that would preclude a bone biopsy, in the opinion of the Investigator.
- 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.
- History of Cushing's disease, hyperthyroidism, hypo- or hyperparathyroidism, or malabsorptive syndromes within the past year.
- 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).
- History of any cancer within the past 5 years (other than basal cell or squamous cell cancer of the skin).
- History of osteosarcoma at any time or a history of hereditary disorders which could predispose the participant to osteosarcoma.
- History of nephrolithiasis or urolithiasis within the past 5 years.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Harvard Medical School
Boston, Massachusetts, 02114
Henry Ford Health System
Detroit, Michigan, 48230
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Panorama Orthopedics & Spine Center
Golden, Colorado, 80401
About this study
Official title: An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
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.
Read the detailed description
This was an open-label, single-arm study of postmenopausal women with osteoporosis treated with 80 micrograms (μg) abaloparatide for 3 months. Transiliac bone biopsies were taken at 3 months after quadruple fluorochrome labeling. The treatment duration of 3 months was determined to be the optimal time when biochemical markers of bone turnover peak and are predictive of subsequent changes in bone mineral density (BMD).
The main study was conducted for a 3-month treatment period with a 1-month follow up. A sub-study was conducted at 1 site to collect peripheral quantitative computed tomography (pQCT) data. Study treatment for participants in the sub-study was extended for an additional 3 months of study drug administration for a total of 6 months of treatment.
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk, Osteoporosis Fracture, Osteoporosis Localized to Spine
- Being tested
- Abaloparatide
- Keywords
- BA058, abaloparatide, TYMLOS®, Bone metabolism, Osteoporosis, Fracture, Bone loss
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures, Fractures, Bone, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbaloparatideDrug
Also called TYMLOS®, BA058
Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH[1-34] and 76% homology to human PTHrP[1-34].
| Study group | Role | What they receive |
|---|---|---|
| Abaloparatide | Experimental | 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. Receives: Drug: Abaloparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
Change in dynamic histomorphometry indices was assessed in the cancellous envelope.
Measured: Baseline (Day 1), Month 3
Secondary outcomes (3)
Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3
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).
Measured: Baseline (Day 1), Month 3
Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3
Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3.
Measured: 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
Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3.
Measured: Baseline (Day 1), Months 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start20 Sep 2018
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Radius Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710889
- Sponsor's protocol ID
- BA058-05-020
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2018
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hattersley G, Dean T, Corbin BA, Bahar H, Gardella TJ. Binding Selectivity of Abaloparatide for PTH-Type-1-Receptor Conformations and Effects on Downstream Signaling. Endocrinology. 2016 Jan;157(1):141-9. doi: 10.1210/en.2015-1726. Epub 2015 Nov 12.
PubMed 26562265Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Valter I, Fitzpatrick LA, Riis BJ, Christiansen C, Bilezikian JP, Black D. 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. Mayo Clin Proc. 2017 Feb;92(2):200-210. doi: 10.1016/j.mayocp.2016.10.009.
PubMed 28160873Dempster DW, Zhou H, Rao SD, Recknor C, Miller PD, Leder BZ, Annett M, Ominsky MS, Mitlak BH. Early Effects of Abaloparatide on Bone Formation and Resorption Indices in Postmenopausal Women With Osteoporosis. J Bone Miner Res. 2021 Apr;36(4):644-653. doi: 10.1002/jbmr.4243. Epub 2021 Jan 28.
PubMed 33434314
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
- ClinicalTrials.gov ID
- NCT03710889
- Acronym / sponsor ID
- BA058-05-020
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk, Osteoporosis Fracture, Osteoporosis Localized to Spine
- Keywords
- BA058, abaloparatide, TYMLOS®, Bone metabolism, Osteoporosis, Fracture, Bone loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Radius Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 15 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was an open-label, single-arm study of postmenopausal women with osteoporosis treated with 80 micrograms (μg) abaloparatide for 3 months. Transiliac bone biopsies were taken at 3 months after quadruple fluorochrome labeling. The treatment duration of 3 months was determined to be the optimal time when biochemical markers of bone turnover peak and are predictive of subsequent changes in bone mineral density (BMD).
The main study was conducted for a 3-month treatment period with a 1-month follow up. A sub-study was conducted at 1 site to collect peripheral quantitative computed tomography (pQCT) data. Study treatment for participants in the sub-study was extended for an additional 3 months of study drug administration for a total of 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abaloparatide | Experimental | Drug: AbaloparatideParticipants 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must meet all of the following criteria to be eligible to participate in this study:
- The participant is a healthy ambulatory postmenopausal female from 50 to 85 years of age (inclusive) with osteoporosis.
- 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).
- 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.
- 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.
Key exclusion criteria (15 listed)
- Participants with any of the following characteristics are not eligible to participate in the study:
- 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.
- Unevaluable hip BMD or participants who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
- History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbaloparatideAlso: TYMLOS®, BA058Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH[1-34] and 76% homology to human PTHrP[1-34]. | Drug | Abaloparatide |
Primary outcome
Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
Time frame: Baseline (Day 1), Month 3
Change in dynamic histomorphometry indices was assessed in the cancellous envelope.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26562265Hattersley G, Dean T, Corbin BA, Bahar H, Gardella TJ. Binding Selectivity of Abaloparatide for PTH-Type-1-Receptor Conformations and Effects on Downstream Signaling. Endocrinology. 2016 Jan;157(1):141-9. doi: 10.1210/en.2015-1726. Epub 2015 Nov 12.
- Background: PubMed 28160873Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Valter I, Fitzpatrick LA, Riis BJ, Christiansen C, Bilezikian JP, Black D. 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. Mayo Clin Proc. 2017 Feb;92(2):200-210. doi: 10.1016/j.mayocp.2016.10.009.
- Derived from this study: PubMed 33434314Dempster DW, Zhou H, Rao SD, Recknor C, Miller PD, Leder BZ, Annett M, Ominsky MS, Mitlak BH. Early Effects of Abaloparatide on Bone Formation and Resorption Indices in Postmenopausal Women With Osteoporosis. J Bone Miner Res. 2021 Apr;36(4):644-653. doi: 10.1002/jbmr.4243. Epub 2021 Jan 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Radius Health, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abaloparatide in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Radius Health, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 (time frame: Baseline (Day 1), Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03710889, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.