UnknownPhase 1

Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

20 participantsStarted 2011-09

Plain-language summary

Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone.

Who can participate

Age range45 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. 8 weeks or longer for any prior use of estrogen and/or progestin products.
✓. 6 months or longer for prior progestin injectable drug therapy.
✓. Women between 45 and 65 years (inclusive) of age.
✓. BMI 22-30 (inclusive)
✓. Non-smoking (by declaration) for a period of at least 6 months.
✓. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.

What they're measuring

Adverse events recorded throughout the study

Timeframe: 4 weeks

Blood and urinalysis values assessed at pre-dose and according to study design.

Timeframe: 4 weeks

Trial details

NCT IDNCT01397838

SponsorOsteoBuild Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

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