Osteoporosis Osteopenia MedDRA version: 12.1 Level: LLT Classification code 10031282 Term: Osteoporosis MedDRA version: 12.1 Level: LLT Classification code 10049088 Term: Osteopenia
Conditions
Interventions
Trade Name: Forsteo
Product Name: Forsteo
Product Code: not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TERIPARATIDE
CAS Number: 52232-67-4
Other descriptive name: Para
Sponsors
MicroCHIPS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Woman age = 50 and = 70 • Postmenopausal by the following criteria: = 12 months since last spontaneous menses, serum FSH value > 20 mIU/L • BMD defined by DEXA spine, total hip, or femoral neck with either a T score =-1.5 (BMD values for spine 1.000 g/cm2 , for total hip 0.820 g/cm2 and for femoral neck 0.800 g/cm2) and >-2.5 (BMD values for spine 0.880 g/cm2, for total hip 0.700 g/cm2 and for femoral neck 0.680 g/cm2) and a history of at least one fragility fracture, or a T-score = -2.5 • Body mass index (BMI) between 18.5 and 29.9 kg/m2. • Judged to be in good health, i.e. without major or clinically relevant pathology, on the basis of medical history, physical examination and routine laboratory measurements (full blood chemistry profile and CBC with differential). • Normal Thyroid function (clinically or with TSH if on thyroid hormone) • Subjects accepts supplemental vitamin D treatment as a booster for 4-6 weeks if serum 25(OH)D at the time of screening is below 20 ng/ml. Maintenance vitamin D / calcium replacement is recommended at the discretion of the physician for the period of the trial. • Subject is willing and able to undergo local anesthesia for both device insertion and explantation. Subject agrees that a tissue biopsy will be taken from the implantation site during explantation. • Subject agrees to avoid physical activity that could put the implant at risk for at least two weeks after device implantation. • Subject understands the nature of the procedures and is willing to comply with associated clinic visits for blood drawings and follow-up evaluations. In the opinion of the investigator, subject can comply with all study requirements. • Subject understands the content and is willing and able to sign the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Exposure to bone active drugs within the past 6 months (e.g. calcitonin, raloxifene, estrogens) any exposure to injectable bisphosphonates (Reclast®) ever, exposure to oral bisphosphonates if used for more than 6 months in the past 5 years or more than one year previously, • Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months, • Current diagnosis of Paget’s disease or unexplained high levels of alkaline phosphatase in blood, • History of any illness that is documented or known and that interferes with bone or calcium metabolism or that might pose an additional risk to the subject or confound the results of the study. This includes, but is not limited to: stones of the kidneys and urinary tract, history of any malignancy and treatment of the condition diabetes, a clinically significant coagulopathy, compromised immune function, hepatitis. • Subject has a history of cardiovascular disease and has a cardiac pacemaker, a cardioverter-defibrillator or a similar device that may be sensitive to radio frequency telemetry. • The patient presents with a baseline hematocrit of <32 %. • Serum 25(OH)D below 10ng/ml. • At the discretion of the investigators a judgment will be made on the withholding of treatment with medications and supplements, i.e. herbal therapies, interfering with bone or calcium metabolism. Maintenance vitamin D/calcium therapy is acceptable. • Subject has a known sensitivity to the relevant drug, to local anesthetic agents, suture materials or implant materials. • The subject has any condition that precludes him/her from completing the protocol. • History of drug or alcohol abuse within 2 years prior to study enrollment. • Subject has a planned MRI prior to anticipated explantation date. • Subject is involved in strenuous contact sports or is required to perform heavy physical workloads. • Subject has participated in a clinical trial of another investigational drug or device within the past 30 days or has not completed the required follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: N/A;Main Objective: The study is being undertaken to assess the pharmacokinetics of hPTH(1-34) as delivered by MicroCHIPS’ implantable delivery system and to evaluate the safety of hPTH(1-34) delivery with this system in postmenopausal women age 50 to 70 with low BMD as defined by DEXA spine, total hip, or femoral neck. This includes women with osteopenia (T-score between -1.5 (BMD values for spine 1.000 g/cm2 , for total hip 0.820 g/cm2 and for femoral neck 0.800 g/cm2) and -2.5 (BMD values for spine 0.880 g/cm2, for total hip 0.700 g/cm2 and for femoral neck 0.680 g/cm2)) and a history of at least one fragility fracture and women with osteoporosis (T-score = -2.5). The results of this trial will be used to support future product development and research efforts. ;Primary end point(s): Subcutaneous releases of hPTH(1-34) shall be assessed from plasma samples and are expected to appear in a pulsatile and reproducible manner. Pharmacokinetic profiles of hPTH(1-34) will be analyzed by calculating AUC, Tmax, Cmax, and elimination rate based on plasma measurements performed on days 4±1, 11±2 and 18±2(subject to change as above) during the device dosing period. Intra- and inter-subject reproducibility/variability parameters of the profiles will be assessed. Initial findings will serve as an estimate for future statistical power calculations. | — |
Countries
Denmark
Outcome results
None listed