Clinical trial NCT04757376: A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Official title: A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Women With Osteoporosis
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 479
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

Detailed description: This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.

Eligibility criteria: Inclusion Criteria:

1. Women, 50 to 80 years of age, both inclusive.
2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
3. Postmenopausal
4. Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
5. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.

Exclusion Criteria:

1. Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
2. Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
3. Patient with history and/or presence of one severe or \> 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
4. Patient with history and/or presence of hip fracture
5. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
6. Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
7. Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
8. Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
timeFrame: baseline (screening), Week 52 predose
Secondary outcomes:
measure: Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS
timeFrame: baseline (screening), Week 52 predose
measure: Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset
timeFrame: baseline (screening), Week 78
measure: Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS
timeFrame: up to Week 52 predose
measure: Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset
timeFrame: from Week 52 to Week 78
measure: Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set
timeFrame: Week 0 Day 1 predose, Week 26 predose
measure: Ctrough of Denosumab at Week 52 - PK-TP II Subset
timeFrame: Week 52
measure: Maximum Serum Concentration (Cmax) of Denosumab After First Dose - PK Set
timeFrame: from baseline (Week 0 Day 1 predose) to Week 26 predose
measure: Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set
timeFrame: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)
measure: Percent Change From Baseline for Serum Concentration of s-CTX at Week 78 - PD-TP II Subset
timeFrame: Baseline (Week 0 Day 1 predose), Week 78
measure: Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set
timeFrame: Baseline (Week 0 Day 1 predose), Weeks 26 and 52 (predose)
measure: Percent Change From Baseline for Serum Concentration of P1NP at Week 78 - PD-TP II Subset
timeFrame: Baseline (Week 0 Day 1 predose), Week 78
measure: Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set
timeFrame: up to Week 52 predose
measure: Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset
timeFrame: from Week 52 to Week 78
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Center For Clinical And Basic Research
state: Harjumaa
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital-Ravi 18
state: Harjumaa
city: Tartu
country: Estonia
facility: Clinical Research Centre Ltd
state: Tartumaa
city: Parnu
country: Estonia
facility: KLV Arstikabinet
city: Liepaja
country: Latvia
facility: Health Center Association, Medical Center Liepaja
city: Riga
country: Latvia
facility: Health Center 4-117 K. Barona Str
city: Wroclaw
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
state: Dolnoslaskie
city: Lódz
country: Poland
facility: SOMED CR Sp. z o.o. Sp. Komandytowa - Lodz
state: Lódzkie
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne
state: Malopolskie
city: Warszawa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: SOMED CR Sp. z o.o. Sp. Komandytowa - Warszawa
state: Mazowieckie
city: Bialystok
country: Poland
facility: NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
state: Podlaskie
city: Gdynia
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
state: Pomorskie
city: Poznan
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
state: Wielkopolskie
city: Skórzewo
country: Poland
facility: Centrum Medyczne Poznan - PRATIA - PPDS
state: Wielkopolskie
city: Kraków
country: Poland
facility: MCM Krakow - PRATIA - PPDS
city: Kyiv
country: Ukraine
facility: AES - AS - Medical Center of Edelweiss Medics LLC
city: Kyiv
country: Ukraine
facility: Clinic of SI Institute of Gerontology n.a. D.F.Chebotaryov of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: AES - AS - Medical Center of Medbud - Clinic LLC
city: Vinnytsia
country: Ukraine
facility: Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
Study officials:
References: