Trial Outcomes & Findings for Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption (NCT NCT03710889)
NCT ID: NCT03710889
Last Updated: 2021-10-15
Results Overview
Change in dynamic histomorphometry indices was assessed in the cancellous envelope.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Baseline (Day 1), Month 3
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
23
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Overall Study
Received at Least 1 Dose of Study Drug
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23
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Overall Study
Bone-Biopsy Population
|
19
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
|
2
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Overall Study
Protocol Deviation
|
1
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Baseline Characteristics
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
Baseline characteristics by cohort
| Measure |
Abaloparatide
n=23 Participants
Participants 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.
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|---|---|
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Age, Continuous
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67.4 years
STANDARD_DEVIATION 8.59 • n=5 Participants
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Sex: Female, Male
Female
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23 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
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Race/Ethnicity, Customized
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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0 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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22 Participants
n=5 Participants
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Race/Ethnicity, Customized
More than one race
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
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Body Mass Index (BMI)
|
23.92 kilogram (kg)/square meter (m^2)
STANDARD_DEVIATION 3.629 • n=5 Participants
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Lumbar Spine Bone Mineral Density (BMD) T-Scores
Total Hip BMD T-Score
|
-2.392 T-Score
STANDARD_DEVIATION 0.6363 • n=5 Participants
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Lumbar Spine Bone Mineral Density (BMD) T-Scores
Femoral Neck BMD T-Score
|
-2.530 T-Score
STANDARD_DEVIATION 0.5708 • n=5 Participants
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Lumbar Spine Bone Mineral Density (BMD) T-Scores
Lumbar Spine BMD T-Score
|
-2.232 T-Score
STANDARD_DEVIATION 1.3098 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1), Month 3Population: The Bone-Biopsy Population included all participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change in dynamic histomorphometry indices was assessed in the cancellous envelope.
Outcome measures
| Measure |
Abaloparatide
n=18 Participants
Participants 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.
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|---|---|
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Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
Baseline
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5.74 percentage of MS/BS
Standard Deviation 3.978
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Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3
Change at Month 3
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18.66 percentage of MS/BS
Standard Deviation 12.114
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SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3Population: The Bone-Biopsy Population included all participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Abaloparatide
n=18 Participants
Participants 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.
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|---|---|
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Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3
Baseline
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0.011 mm^3/mm^2/year
Standard Deviation 0.0076
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Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3
Change at Month 3
|
0.034 mm^3/mm^2/year
Standard Deviation 0.0245
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SECONDARY outcome
Timeframe: Baseline (Day 1), Months 1 and 3Population: The Bone-Biopsy Population included all enrolled participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Number Analyzed' signifies participants evaluable for the specified categories.
Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3.
Outcome measures
| Measure |
Abaloparatide
n=19 Participants
Participants 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.
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|---|---|
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Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3
Baseline
|
54.990 nanograms (ng)/milliliter (mL)
Interval 38.43 to 79.16
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Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3
Change at Month 1
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119.155 nanograms (ng)/milliliter (mL)
Interval 62.81 to 242.24
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Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3
Change at Month 3
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141.130 nanograms (ng)/milliliter (mL)
Interval 53.42 to 236.98
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SECONDARY outcome
Timeframe: Baseline (Day 1), Months 1 and 3Population: The Bone-Biopsy Population included all enrolled participants who received an evaluable biopsy (defined as a biopsy sample that can be analyzed in the laboratory). Here, 'Number Analyzed' signifies participants evaluable for the specified categories.
Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3.
Outcome measures
| Measure |
Abaloparatide
n=19 Participants
Participants 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.
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|---|---|
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Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3
Baseline
|
0.460 ng/mL
Interval 0.308 to 0.549
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Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3
Change at Month 1
|
0.052 ng/mL
Interval -0.109 to 0.174
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Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3
Change at Month 3
|
0.311 ng/mL
Interval 0.079 to 0.694
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Adverse Events
Abaloparatide
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abaloparatide
n=23 participants at risk
Participants 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.
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|---|---|
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Cardiac disorders
Atrial fibrillation
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4.3%
1/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Gastrointestinal disorders
Vomiting
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4.3%
1/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Other adverse events
| Measure |
Abaloparatide
n=23 participants at risk
Participants 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.
|
|---|---|
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Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Gastrointestinal disorders
Nausea
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17.4%
4/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Infections and infestations
Upper respiratory tract infection
|
8.7%
2/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Injury, poisoning and procedural complications
Fall
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8.7%
2/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Musculoskeletal and connective tissue disorders
Bursitis
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13.0%
3/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Nervous system disorders
Dizziness
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17.4%
4/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Nervous system disorders
Headache
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13.0%
3/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.7%
2/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Skin and subcutaneous tissue disorders
Ecchymosis
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8.7%
2/23 • Baseline (Day 1) up to Month 4 (main study) and Month 7 (sub-study)
The Safety Population included all enrolled participants who received at least one dose of abaloparatide.
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Additional Information
Associate Director, Clinical Operations
Radius Health, Inc.
Phone: (617) 551-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/\> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/\> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
- Publication restrictions are in place
Restriction type: OTHER