The Effect of Raloxifene on Serum IGF-I in Patients with Acromegaly on long-term Octeotide Treatment - Raloxifene in Patients with Acromegaly on Octreotide

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004989-14-GB

Enrollment

Registered

2006-10-09

Start date

2007-01-12

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acromegaly

Interventions

Trade Name: Evista 60mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RALOXIFENE CAS Number: 84449901

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Man and postmenopausal women with acromegaly Fixed dose of Sandostatin®LAR® for at least three months prior to enrolment Over 18 years of age Safe prolactin levels 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: History of deep vein thrombosis and/or pulmonary embolism Other conditions known to alter GH/IGF-I (severe hepatic disease, severe renal disease, malnutrition, alcohol and drug abuse) History of relevant food and drug allergies Pregnancy/lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Acromegaly is a rare disease caused by excessive growth hormone (GH) production usually from a benign pituitary tumour. Insulin-like growth factor-I (IGF-I) is the main mediator of GH action and a marker of disease activity. There are various treatment options for patients with acromegaly: trans-sphenoidal surgery (treatment of choice) dopamine agonists, somatostatine analogues and GH receptor antagonist. Their success rate varies from 35-97%, with higher efficacy being associated with higher cost of treatment. It is known that oestrogen can alter GH and IGF-I and cause symptom improvement in women with acromegaly, but it cannot be given to men. Recently, 2 pilot studies used raloxifene (60 and 120 mg) in women and men with acromegaly and achieved reduction in IGF-I and improvement of symptoms without any side-effects. The aim of this study is to investigate the effect of raloxifene on IGF-I in patients with acromegaly already on a somatostatin analogue - octreotide. ; Secondary Objective: 1. to document changes in symptoms and signs and quality of life, if any, in relation to raloxifene treatment 2. to observe what happens to GH and relevant binding proteins (GHBP, IGFBP1-3, ALS), remaining pituitary function and insulin sensitivity 3. to record adverse events, if any. ;Primary end point(s): The primary endpoint assessed will be IGF-I change following the additional raloxifene (Evista®) to ongoing octreotide (Sandostatin®LAR®) treatment.	—

Measure

Time frame

Main Objective: Acromegaly is a rare disease caused by excessive growth hormone (GH) production usually from a benign pituitary tumour. Insulin-like growth factor-I (IGF-I) is the main mediator of GH action and a marker of disease activity. There are various treatment options for patients with acromegaly: trans-sphenoidal surgery (treatment of choice) dopamine agonists, somatostatine analogues and GH receptor antagonist. Their success rate varies from 35-97%, with higher efficacy being associated with higher cost of treatment. It is known that oestrogen can alter GH and IGF-I and cause symptom improvement in women with acromegaly, but it cannot be given to men. Recently, 2 pilot studies used raloxifene (60 and 120 mg) in women and men with acromegaly and achieved reduction in IGF-I and improvement of symptoms without any side-effects. The aim of this study is to investigate the effect of raloxifene on IGF-I in patients with acromegaly already on a somatostatin analogue - octreotide. ; Secondary Objective: 1. to document changes in symptoms and signs and quality of life, if any, in relation to raloxifene treatment 2. to observe what happens to GH and relevant binding proteins (GHBP, IGFBP1-3, ALS), remaining pituitary function and insulin sensitivity 3. to record adverse events, if any. ;Primary end point(s): The primary endpoint assessed will be IGF-I change following the additional raloxifene (Evista®) to ongoing octreotide (Sandostatin®LAR®) treatment.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026