NCT04366726CompletedPhase 1
A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Radius Health, Inc.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
Study Overview
Brief Summary
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
Detailed Description
This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Postmenopausal for at least 2 years
- •BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)
- •Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2)
- •Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
- •Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)
Exclusion Criteria
- •History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine
- •History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease)
- •History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
- •History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year
- •Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84)
- •Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment
- •Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer
Arms & Interventions
abaloparatide-sMTS
Experimental
Abaloparatide-sMTS 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days.
Intervention: abaloparatide-sMTS (Combination Product)
Outcomes
Primary Outcomes
Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
Time Frame: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29
Time Frame: 0 (predose) and 4 hours postdose on Day 29
Secondary Outcomes
- Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29(Baseline, 0 (predose) and 4 hours postdose on Day 29)
- Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29(Baseline, 0 (predose) and 4 hours postdose on Day 29)
- Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29(Baseline, 0 (predose) and 30-minutes postdose on Day 29)
- Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29(Baseline, Day 29)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic CancerChemotherapy EffectPancreatic CancerNCT04581876Fudan University120
Withdrawn
Phase 2
Ease of Use, Tolerability, Efficacy and Safety of the Vibrant Capsule Administered in the Home EnvironmentConstipationNCT02895516Vibrant Ltd.
Completed
Phase 4
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.HIV InfectionsNCT00326963Hoffmann-La Roche142
Unknown
Phase 2
Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG RegimenMetastatic Pancreatic CancerNCT04101929Fudan University126
Terminated
Phase 3
A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic TherapyCarcinoma, HepatocellularNCT04732286Hoffmann-La Roche100