How does raloxifene influence the effects of growth hormone replacement

Modulation of growth hormone action during growth hormone replacement in growth hormone-deficient women: comparison of raloxifene and oral oestrogen

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000532606

Enrollment

Registered

2005-09-28

Start date

2002-09-05

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Raloxifene is a member of a family of compounds called selective estrogen receptor modulators (SERMS) that exert many of the beneficial effects of estrogen replacement without the associated increase in risk of breast and uterine cancer. Growth hormone (GH) replacement is beneficial in adults with hypopituitarism. Most GH deficient women also require oestrogen replacement. Oral oestrogens antagonise GH action at the liver, thereby reducing its beneficial effects on body composition and metabolism. The aim of this study is to investigate whether SERMs exert less of a negative influence on the effects of GH replacement, and therefore would be superior to conventional estrogen replacement in this setting.

Interventions

Raloxifene (60 mg daily) for 6 - 18 months 17 beta oestradiol (2 mg) for 6 - 18 months recombinant uman growth hormone (Humaloge) (0.5 mg daily) for 24 months

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Hypopituitarism (deficient in growth hormone and sex steroids).

Exclusion criteria

No exclusion criteria

Outcome results