The Scandinavian investigation of primary hyperparathyroidism (pHPT) – end of inclusion and preliminary results

JB Bollerslev; SJ Jansson; CLM Mollerup; JN Nordenström; EL Lungren; OT Tørring; CF Franco; JEV Varhaug; GAI Isaksen; TR Rosen

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Endocrine Abstracts (2006) 11 OC56

ECE2006 Oral Communications Calcium and bone OC49 Novartis Oncology Young Investigator Award (8 abstracts)

The Scandinavian investigation of primary hyperparathyroidism (pHPT) – end of inclusion and preliminary results

JB Bollerslev ¹ , SJ Jansson ² , CLM Mollerup ³ , JN Nordenström ⁴ , EL Lungren ⁵ , OT Tørring ⁶ , CF Franco ⁷ , JEV Varhaug ⁸ , GAI Isaksen ¹ & TR Rosen ⁷

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¹Section of Endocrinology, National Hospital, Oslo, Norway; ²Department of Surgery, Sahlgrenska Hospital, Gothenburg, Sweden; ³Department of Surgery, Rigshospitalet, Copenhagen, Denmark; ⁴Department of Surgery, Karolinska Hospital, Stockholm, Sweden; ⁵Department of Surgery, Uppsala Hospital, Uppsala, Sweden; ⁶Department of Endocrinology, Karolinska Hospital, Stockholm, Sweden: ⁷Department of Endocrinology, Sahlgrenska Hospital, Gothenburg, Sweden, ⁸Department of Surgery, Haukeland Hospital, Bergen, Norway.

Background: From 1999 to the end of June 2005, 186 patients (26 men) with truly asymptomatic pHPT based on the NIH 1990 criteria were included at 11 centres in Scandinavia. The mean age at inclusion was 63.2±7.8 (S.D.) years. After informed consent the patients were randomised to operation (93) or medical observation (94), in order to investigate the effect of operation on Quality of Life and co-morbidity. At present, 159 patients are ongoing, 3 dead, and 24 have withdrawn. Follow-up data after 1 year were available for 117 patients equally distributed between the two groups.

Results: At baseline, mean s-calcium was 2.69±0.07 mM, s-PTH 10.3±4.2 pM and s-creatinine 80.7±14.7 μM, equally distributed between the groups. Compared to normative Swedish data, the patient population showed significantly lower SF-36 score in the mental health related domains. Bone mineral density (BMD) at baseline was without difference from normative data. During follow up, calcium and PTH levels were unchanged in the observation group, but normalized in the operated group, as expected. Creatinine level was unchanged in both groups and without difference. BMD in the spine and femoral neck did not change in the observation group, whereas significant increases were found in the operated patients. SF-36 scores did not differ between the groups at baseline or after 1 year of observation. Within the groups only minor changes in SF-36 were observed.

Conclusion: 189 truly asymptomatic patients with pHPT were included in the study and 159 are ongoing. At baseline the patients had decreased QoL as judged by SF-36 compared to normative data. The normalization of PTH and Ca-levels following parathyroidectomy was associated with increases in BMD of the spine and femoral neck; however QoL did not improve. The total follow-up time is planned to be 10 years.