Not Yet RecruitingPhase 4ACTRN12621000728831

Open-Label Study to Evaluate the Inter-subject Variability of Single Dose Prolia Pharmacokinetics and Pharmacodynamics, Administered by Subcutaneous Injection in Healthy Postmenopausal Women

Sponsor

Christchurch Clinical Studies Trust

Enrollment

20 participants

Start Date

Jul 14, 2021

Study Type

Interventional

Conditions

Osteoporosis

Summary

Single-center, single-arm, open-label study of Prolia administered subcutaneously in healthy post menopausal women. The study is designed to provide single-dose pharmacokinetic inter-subject variability data for prolia, to optimize study design (including sample size calculation) for a proposed Prolia biosimilar pivotal PK study.

Eligibility

Sex: FemalesMin Age: 40 Yearss

Inclusion Criteria8

Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, active malignancy, renal disease
Previous treatment with denosumab.
Receipt of any therapy that may significantly affect bone turnover, e.g., bisphosphonates within 12 months; or estrogens, selective estrogen receptor modulators, calcitonin, parathyroid hormone, high doses of Vitamin D (Greater than 1,000 IU daily), anabolic steroids, systemic glucocorticosteroids, or calcitriol within 6 months prior to IP administration.
Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery within 6 months prior to IP administration), poor oral hygiene, periodontal, and/or pre-existing dental disease.
Evidence of hypocalcaemia, Known vitamin D deficiency.
Any current active infection, Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Human Immunodeficiency Virus (HIV) at screening.
A recent history of major surgery (within 3 months prior to IP administration).
History or presence of malignancy

Exclusion Criteria8

Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, active malignancy, renal disease
Previous treatment with denosumab.
Receipt of any therapy that may signi?cantly affect bone turnover, e.g., bisphosphonates within 12 months; or estrogens, selective estrogen receptor modulators, calcitonin, parathyroid hormone, high doses of Vitamin D (Greater than 1,000 IU daily), anabolic steroids, systemic glucocorticosteroids, or calcitriol within 6 months prior to IP administration.
Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery within 6 months prior to IP administration), poor oral hygiene, periodontal, and/or pre-existing dental disease.
Evidence of hypocalcemia, Known vitamin D deficiency.
Any current active infection, Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Human Immunodeficiency Virus (HIV) at screening.
A recent history of major surgery (within 3 months prior to IP administration).
History or presence of malignancy

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Interventions

Approximately 20 healthy post menopausal women will each receive a single 6mg dose of Prolia, as an injection under the skin in the abdomen. The SC injection will be given by a registered nurse.