Clinical Trial 39568

San Antonio, TX 78209


Study Summary:

ICON Early Phase Services is conducting a research study for postmenopausal women between the ages of 55 and 90.  This study is being conducted with an investigational drug for the treatment of osteoporosis. This is a device study comparing dosing methods (autoinjector pen or a prefilled syringe).

Vital signs, ECGs, physical examinations, DEXA scans, bone mineral density assessments, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

  •  1 screening visit
  •  8 outpatient visits

To determine if you fully qualify, it will be necessary to obtain blood samples after a 8- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.  For more information, see below.



If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am an ambulatory postmenopausal (for at least 12 consecutive months) female with osteoporosis

 

  • I am between ≥ 55 and ≤ 90 years old

 

  • I am not currently receiving treatment in another investigational device or drug study, or, it has been more than 30 days since ending treatment on another investigational device or drug study(ies)

 

  • I am able to communicate effectively in English with the study personnel

 

  • I have a history of fragility (i.e., osteoporosis-related fracture) or I have several risk factors for fracture

 

  • I do not have osteonecrosis of the jaw (ONJ) events

 

  • I do not have atypical femoral fractures (AFF)
  • I do not have a history of metabolic or bone disease  (except osteoporosis) that may interfer with the interpretationof the results, such as sclerostieosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome

 

  • I do not have a history of hearing loss associated with cranial nerve compression due to excessive bone growth

 

  • I do not have a vitamin D deficiency

 

  • I do not have hyperthyroidism (unless well controlled on stable antithyroid therapy)

 

  • I do not have hypothyroidism (unless well controlled on stable thyroid replacement therapy)

 

  • I do not currently have uncontrolled hyper- or hypoparathyroidism

 

  • I do not currently have hyper- or hypocalcemia

 

  • I do not have a malignancy (except non-melanoma skin cancers or cervical or breast ductal carcinoma in situ within the last 5 years

 

  • I do not have multiple myeloma or any related lymphoproliferative disorder

 

  • I do not have a history of any severe or life-threatening allergies (e.g., food or drugs or latex)

 

  • I tolerate oral medication well

 

  • I have not had problems having blood drawn in either arm, venous access or finger pricks.

 

  • Exclusion criteria for medications and treatment:

 

drug;  dosing;   timeline

Strontium ranelate or fluoride (for osteoporosis); more than 1 month of cumulative use within 5 years, prior to dosing;

Intravenous (IV) bisphosphonates: Zoledronic Acid; any dose within 3 years; prior to dosing or more than 1 dose within 5 years;  prior to dosing

Intravenous (IV) bisphosphonates: IV ibandronate or IV pamidronate: any dose within 12 months; prior to dosing  or more than 3 years of cumulative use;  unless last dose received  ≥ 5 years prior to dosing

denosumab,  any cathepsin K inhibitor, such as odanacatib (MK-0822); within the past 18 months; prior to dosing

Teriparatide or any PTH analogs; any dose received; within 3 months prior to dosing   or more than 1 month of cumulative use;  between 3 and 12 months prior to dosing

Oral bisphosphonates; any dose; within 3 months prior to dosing  or  more than 1 month of cumulative use; between 3 and 12 months prior to dosing or  more than 3 years of cumulative use; unless last dose received  ≥ 5 years prior to dosing

systemic oral or transdermal estrogen or SERMs; any dose (NOTE: up to 1 month of cumulative use is allowed); within the past 6 months prior to dosing

activated vitamin D3 or vitamin K2; more than 1 month of cumulative use; within 6 months prior to dosing

hormonal ablation therapy; any dose; within 6 months prior to dosing

tibolone, calcitonin, or cinacalcet; any dose; within 3 months prior to dosing

systemic glucocorticosteroids;  any dose (NOTE: ≥ 5 mg prednisone equivalent per day for more than 14 days); within 3 months prior to dosing

sclerostin antibody product; any dose; within 12 months prior to dosing

 

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.  Frequently, subjects do not qualify because of medical history or minor changes in vital signs, ECG and lab tests.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  Additionally, no guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment.  We will be testing for tobacco and drug abuse.  Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID and your Social Security Card with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, or passport.  Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records.

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation. 
  • All physical, occupational and rehab requests, consultations and progress notes.
  • All laboratory, histology, cytology, pathology and radiology records, results and reports.
  • All pharmacy/prescription records.


Qualified Participants May Receive:

Qualified participants may be compensated up to $525 for time and travel.


View Contact Phone Number


Study is Available At:

ICON Early Phase Services, LLC
8307 Gault Lane
San Antonio, TX 78209
View Clinic Location

 


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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.